• Lascure Laser Helmet Hat-01
  • Lascure Laser Helmet Hat-01
  • Lascure Laser Helmet Hat-01
  • Lascure Laser Helmet Hat-01
  • Lascure Laser Helmet Hat-01
  • Lascure Laser Helmet Hat-01
  • Lascure Laser Helmet Hat-01
  • Lascure Laser Helmet Hat-01
  • Lascure Laser Helmet Hat-01
Lascure Laser Helmet Hat-01
Lascure Laser Helmet Hat-01
Lascure Laser Helmet Hat-01
Lascure Laser Helmet Hat-01
Lascure Laser Helmet Hat-01
Lascure Laser Helmet Hat-01
Lascure Laser Helmet Hat-01
Lascure Laser Helmet Hat-01
Lascure Laser Helmet Hat-01
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Lascure Laser Helmet Hat-01


FDA Cleared 510(k) K232356- Laser Hair Growth System

For Hair-Growth Brands, Distributors and Amazon Volume Sellers

80 × 650nm Lasers · 30-Minute Smart Auto-Shutoff

Developed in ISO13485 Certified facilities · OEM/ODM Available

Cordless Freedom with Built-In Lithium Battery

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Lascure Laser Helmet Hat-01

Specifications

Laser Helmet 82 (HAT-01) Technical Specifications

A lightweight cordless laser hair-growth platform engineered with 80 × 650nm VCSEL laser diodes, one-touch operation and rechargeable battery power.

Optical System Treatment Protocol Physical & Electrical
Light Source
80 × VCSEL laser diodes
Session Duration
30 min · Auto shut-off
Battery Capacity
3,800 mAh
Wavelength
650 nm ±10 nm
Recommended Frequency
3 sessions per week
Charging Time
Approx. 4 hours
Single Diode Power
5 mW ±20%
Laser Operating Modes
Continuous and pulse
Runtime
Approx. 2.5 hours
Total Optical Output
400 mW
Pulse Frequency
2 Hz
Weight
484 g
Irradiance
3.54 mW/cm²
  Dimensions (L × W × H)
250 × 225 × 140 mm
Energy Density
6.372 J/cm²
  Head Circumference
51–61 cm
(20.08–24.02 in)
Laser Classification
Class 3R
   

 

CORE ADVANTAGE

80 × Medical-Grade VCSEL Lasers

Powered by 80 VCSEL laser diodes at 650nm ±10nm, delivering focused optical energy without an LED mixed-light matrix.

EFFORTLESS OPERATION

One-Touch Daily Treatment

Simple one-button control allows users to start a complete 30-minute treatment session without complicated setup.

CORDLESS FREEDOM

3,800mAh Rechargeable Battery

Built-in lithium battery supports cordless treatment sessions without restricting users with external cables.

LIGHTWEIGHT DESIGN

Only 484g

A lightweight ergonomic dome design supports comfortable home use and easy integration into everyday treatment routines.

OEM ADVANTAGE

Built for Scalable Private Label

Support logo customization, packaging, localized manuals and broader OEM/ODM solutions for hair-growth brands and distributors.

GLOBAL COMPLIANCE

FDA-Cleared Platform

FDA 510(k) cleared under K232356 and developed in ISO 13485 certified manufacturing facilities.

Lascure HAT-01 Cordless Laser Hair Growth Helmet

EFFORTLESS DAILY THERAPY

One-Touch Cordless Control for Effortless Daily Treatment

Designed for maximum compliance and ease of use, HAT-01 combines a simple one-button treatment protocol with a built-in rechargeable battery—no complex setup or tangled cords required.

One-Touch Operation

Simple one-button control starts the complete daily treatment session instantly.

30-Minute Auto Stop

Automatic shutoff at the end of each session supports consistent daily treatment.

Cordless Battery Freedom

A built-in 3,800mAh rechargeable lithium battery enables convenient cordless use.

650nm VCSEL Laser

The VCSEL laser matrix delivers focused 650nm optical energy across the scalp.

✓ One-touch activation    ✓ Cordless battery freedom
✓ Full-scalp coverage    ✓ Ultra-lightweight ergonomic build

Lascure HAT-01 VS Competitive Product

A practical comparison highlighting the cordless design, laser configuration, battery capability and OEM flexibility of Laser Helmet 82 (HAT-01).

Features Lascure HAT-01
Lascure HAT-01
Competitive Hair Growth Device
Competitive Product
FDA Cleared
Laser Configuration 80 × VCSEL Lasers 51 Lasers + 69 LEDs
Wavelength 650nm ±10nm Model Dependent
Treatment Time 30 Minutes 25 Minutes
Operating Modes Continuous + Pulse Continuous
Cordless Operation X
Battery Capacity 3,800mAh Rechargeable Non-Rechargeable / Model Dependent
OEM / Customization X

 

 

 

Applications

REGULATORY STATUS & INTENDED USE

Application Scope

Laser Helmet 82 (HAT-01) is FDA-cleared under 510(k) K232356 and designed for home-use hair-growth applications in accordance with the indications and operating conditions specified in the cleared product labeling.

01

Hair-Growth Support

Designed for eligible male and female users as part of an established home-use hair-growth program.

02

Androgenetic Alopecia

Intended for androgenetic alopecia applications within the user groups and conditions covered by the cleared indication.

03

Fuller-Looking Hair

Designed to support an ongoing hair-care routine for users seeking healthier and fuller-looking hair.

04

Home-Use Maintenance

Cordless one-touch operation supports convenient integration into a regular at-home hair-care routine.

Laser Helmet 82 HAT-01

FDA-Cleared Hair Growth Platform

Laser Helmet 82 (HAT-01) is FDA-cleared under 510(k) K232356 and manufactured under an ISO 13485 quality-management system.

Designed for hair-growth applications including:
✓ Male and female hair-growth programs
✓ Androgenetic alopecia (AGA)
✓ Hair thinning and scalp-care support
✓ Adjunctive / combination-care programs

BUILT FOR CHANNEL GROWTH

One Versatile Platform, Three Scalable Routes to Market

Designed to help partners launch a scalable laser hair-growth line without long R&D cycles or major hardware investment.

01

E-Commerce & Hair-Care Brands

Private-label hardware, custom gift packaging and localized manuals designed for rapid mass-market acquisition and high-value bundle kits.

02

Retail Distributors & Chain Pharmacies

An FDA-cleared home-use laser helmet supported by channel-exclusive SKU strategies and MAP policy support for healthier retail margins.

03

Salons & Wellness Clinics

An accessible professional take-home LLLT solution suitable for client demonstrations, retail conversion and home-treatment continuity.

Commercial Support for Global Partners

✓ Private-label & OEM projects
✓ Customized gift packaging
✓ Localized user manuals
✓ Channel-exclusive SKU support
✓ MAP policy support

 

 

Unique selling points

BUILT FOR BRAND GROWTH

What Laser Helmet 82 (HAT-01) Adds to Your Product Portfolio

Laser Helmet 82 is engineered as a high-margin volume driver for ambitious hair-growth brands and channel partners—far beyond a standard private-label product.

Laser Helmet 82 HAT-01 Product Portfolio
01

An Accessible Hero Volume Driver

Lower the entry barrier for first-time LLLT hair-growth consumers with a cost-effective classic dome helmet designed to support rapid customer acquisition and high order volume.

02

Higher Retail Margin Potential

A competitive sourcing structure can provide stronger margin flexibility for paid marketing, distributor programs and retail promotions compared with higher-cost competitive devices.

03

High-AOV Kit Bundling Potential

Pair HAT-01 with topical serums, anti-hair-loss shampoos or scalp-care products to create premium “Hardware + Formula” hair-growth kits and increase average order value.

04

Immediate In-Store Product Trust

The classic medical-style dome design supports familiar, professional product presentation in pharmacies, salons and retail chains, helping facilitate product demonstrations and customer education.

05

Compliance-Ready Market Entry

Backed by FDA 510(k) clearance and regulatory documentation support, HAT-01 helps qualified partners streamline product review, import preparation and commercial market entry.

 

 

Product video

 

OEM Customization Service


PRIVATE LABEL

Customized Branding Solution

We can replace the Lascure logo with your own brand identity, while supporting customized packaging design, user manual language and product presentation materials.

PRODUCT DESIGN

Customized Laser Helmet Color

The device supports customized appearance options to match your brand positioning, including Black, Gray, Red and other customized color solutions.

  • Customized Laser Comb Color
    • Original Original
    • Black Black
    • Black&red Black&red
    • White &red White &red
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PRIVATE LABEL

Customized Branding Solution

We can replace the Lascure logo with your own brand identity, while supporting customized packaging design, user manual language and product presentation materials.

PRODUCT DESIGN

Customized Laser Helmet Color

The device supports customized appearance options to match your brand positioning, including Black, Gray, Red and other customized color solutions.

  • Customized Laser Comb Color
    • Original Original
    • Black Black
    • Black&red Black&red
    • White &red White &red

ODM Customization Service

PRODUCT DEVELOPMENT PROCESS

From Concept To Production

A complete product development pathway from feasibility evaluation to mass manufacturing.

Feasibility Study

STEP 01

Feasibility Study

Lascure provides expert evaluation of customized projects to objectively identify strengths and weaknesses, ensuring overall feasibility and effectiveness.

Our internationally accredited CNAS laboratory supports EMC, RE, RS, CE, Optical Laboratory and Environmental Reliability testing.

STEP 02

Industrial Design

Lascure has professional ID designers delivering innovative, brand-enhancing designs that attract customers.

A streamlined design process ensures every concept is optimized for production readiness.

Industrial Design
Engineering and Prototyping

STEP 03

Engineering & Prototyping

Lascure engineers transform concepts into functional prototypes by combining engineering accuracy with efficient development.

Rapid prototyping helps accelerate product validation and shorten time-to-market.

STEP 04

Manufacturing

With advanced manufacturing facilities and strict quality control systems, Lascure delivers reliable mass production according to approved samples.

Manufacturing

SUPPORT & INFORMATION

Frequently Asked Questions

01 What is the MOQ and lead time for Laser Helmet 82 (HAT-01)? +
Sample Orders: MOQ is 1 unit. Samples are typically dispatched within 3–5 business days for evaluation.

Custom / Private Label Orders: OEM branding for logo, packaging and user manuals can start from relatively small quantities depending on project requirements.

Production Lead Time: Standard bulk production typically requires 25–30 days after order confirmation and artwork approval.
02 What is the FDA 510(k) status, and can we sell under our own brand? +
Laser Helmet 82 (HAT-01) is FDA 510(k) cleared under K232356.

The cleared indication covers eligible male and female users with androgenetic alopecia within the applicable labeling and Fitzpatrick Skin Types I–IV.

LASCURE can also provide Letters of Authorization (LOA) and regulatory support for qualified global partners to assist with local medical-device listing and compliance procedures.
03 What is your warranty and B2B after-sales (RMA) policy? +
LASCURE provides a 3-year limited warranty for Laser Helmet 82.

To reduce international logistics costs for B2B partners, defective units under warranty do not necessarily need to be returned to China.

After video or diagnostic verification, eligible cases may be handled through replacement units or credit notes, which can be consolidated with the partner’s next bulk shipment.
04 Why choose 650nm VCSEL laser technology over traditional LED light? +
HAT-01 uses a dedicated 650nm VCSEL laser matrix rather than a mixed LED light-source configuration.

Focused Optical Delivery: VCSEL technology provides a more directional and consistent optical source compared with conventional diffuse LED illumination.

Pure Laser Platform: Laser Helmet 82 uses 80 VCSEL laser diodes, providing a focused low-level laser platform for scalp-care and hair-growth applications.
05 Can LASCURE support distributor and private-label due diligence? +
Yes. LASCURE works with international healthcare brands, importers, distributors and professional channels.

Commercial and technical review support may include:
✓ Non-Disclosure Agreements (NDA) before technical disclosure
✓ Third-party factory audits such as TÜV, SGS or Intertek
✓ Territory or channel-exclusive SKU agreements for qualified volumes
✓ Minimum Advertised Price (MAP) policy support
✓ Technical Data Sheet, test reports and compliance documentation
06 What certifications and test reports are included in the Compliance Pack? +
The technical documentation package available to verified buyers may include:

✓ ISO 13485 quality-system documentation
✓ FDA 510(k) clearance documentation
✓ CE-related technical documentation
✓ IEC 60601-1 medical electrical safety testing
✓ IEC 60601-1-2 EMC testing
✓ IEC 60825-1 Class 3R laser safety testing
✓ RoHS documentation
✓ UN38.3 lithium-battery transportation safety documentation
07 How do you protect OEM/ODM partners from price wars and channel conflict? +
For qualified partners, LASCURE supports structured channel-protection programs.

Channel / Territory Exclusivity: Exclusive cooperation can be discussed by territory, industry channel or customized SKU based on agreed annual volumes.

Design & Mold Protection: Proprietary OEM designs and tooling are protected under confidentiality agreements.

Pricing Integrity: MAP guidelines can be supported in major markets to help protect brand positioning and distributor margins.
08 Does the device comply with international lithium-battery shipping requirements? +
Laser Helmet 82 features a built-in 3,800mAh lithium-ion battery.

Battery logistics documentation may include:
✓ UN38.3 Test Report & Summary
✓ MSDS (Material Safety Data Sheet)
✓ 1.2m Drop Test documentation
✓ Air and sea transport safety declarations
✓ PI967 / Section II related transport documentation where applicable
09 Beyond logo printing, what OEM/ODM customization options are available? +
LASCURE supports multi-level OEM/ODM customization.

Industrial Design:
✓ Custom outer-shell colors
✓ Surface finishes such as matte, metallic or UV coating
✓ Silicone liner modification

Optical Engineering:
✓ Customized diode configurations
✓ Laser output options
✓ Wavelength combinations subject to technical evaluation

Packaging & Collateral:
✓ Custom gift-box design
✓ Custom travel case
✓ Regional power-adapter plugs
✓ Localized user manuals
10 Can hair-care and serum brands bundle HAT-01 with topical products? +
Yes.

HAT-01 can serve as a hero hardware product within a broader hair-care bundle, allowing brands to combine the device with topical serums, shampoos or other compatible hair-care products.

LASCURE can also support customized packaging solutions, including gift-box sizing and internal tray configurations designed to accommodate both the HAT-01 helmet and partner-branded products within one unified package.

Company Certifications

ISO9001

FDA Certificate

510K K253231

Issue by FDA

ISO9001

FDA Certificate

510K:K230134

Issue by FDA

ISO9001

FDA Certificate

510K:k232356

Issue by FDA

ISO9001

ISO9001

Number:CN23/00005469

Issued by SGS

ISO9001

ISO 13485

Number:No,Q5 122071

Issued by TUV

ISO9001

Medical CE

Number No.:0120

Issue by SGS

ISO9001

CFS

Number No.20240187

Issue by CFDA

ISO9001

CFDA certificate

No.:20252095513

Issue by NMPA

Get a Quote

For inquiries, reach out by Email, WhatsApp, or phone. The marketing team will respond you within 12 working hours

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FAQs

How do you prevent price erosion from online platforms (e.g., Amazon) from impacting our physical or professional medical channels?

We enforce a strict MAP (Minimum Advertised Price) policy. For major distributors, we utilize a "Model Isolation" strategy. The Lascure 352 can be positioned as an exclusive SKU for professional channels or high-end chains, with distinct industrial design and packaging, shielding our partners from online price wars and protecting your pricing power.

Why does Lascure insist on "Pure Laser" instead of the popular "Laser + LED" hybrid models?

This is a critical differentiator. While LEDs only provide superficial light, they lack the coherence to reach the hair follicle root. Lascure 352 uses 100% medical-grade cold laser diodes. In the professional market, this "Pure Laser" configuration represents a higher clinical standard, allowing you to maintain premium pricing and avoid the race-to-the-bottom price wars of LED hybrids.

Is the FDA clearance sufficient for entry into professional medical clinics in North America?

Beyond FDA 510(k) clearance, our facility is ISO 13485 certified. We provide a comprehensive Clinical White Paper that empowers your sales team to pitch to dermatologists with superior specs compared to legacy brands like HairMax (352 Diodes vs. 82/272 Diodes).

North American consumers can be impatient regarding results. How do we manage their expectations?

With its ultra-dense 650nm energy coverage, Lascure 352 shortens the average clinical visibility window from the industry-standard 24 weeks to 16-20 weeks. Our integrated app and "Scalp Progress Tracker" foster user engagement, using digital visualization to reduce early-stage abandonment and boost long-term satisfaction.

Users on Reddit/Amazon often dismiss LLLT devices as "expensive plastic toys." How does Lascure 352 establish a premium medical-grade feel?

We utilize medical-grade high-transmittance polymers and a sleek industrial design to move beyond the "plastic toy" perception. The sheer density of 352 real laser diodes provides an immediate visual sense of professional efficacy. Our weight-balance system, tested on 500+ North American volunteers, ensures zero pressure, significantly reducing "discomfort-related returns" in retail channels.

Consumers often worry about safety or accidental eye exposure. What safeguards are in place?

Lascure 352 is equipped with intelligent proximity sensors. The device only activates when securely placed on the head and automatically shuts off the moment it’s removed. This eliminates safety concerns regarding accidental eye exposure in households, fully aligning with North American ANSI safety standards.

What is the core advantage of 352 diodes compared to HairMax or brands with only 80-200 diodes?

Density determines depth. Lascure 352 provides full-scalp coverage, eliminating the need for manual movement like the HairMax comb and avoiding the "blind spots" of low-diode caps. Our 352 pure 650nm lasers create a uniform, potent energy field (LLLT), with clinical data showing follicles activation efficiency roughly 40% higher than leading competitors. This translates to faster, visible results for the user.

How do you support after-sales and warranties? High return rates are profit killers in North America.

We minimize defect rates by using 352 high-quality laser diodes instead of cheap LEDs. We offer a 2-year warranty and are open to establishing North American localized R&A processes or providing a "buffer stock" percentage to offset retail returns and protect your bottom line.

What are your OEM/ODM capabilities and supply chain stability for high-volume orders?

We operate vertically integrated production lines capable of meeting the massive demands of North American retail giants. We offer deep OEM/ODM customization, ranging from shell color and logo branding to bespoke software interfaces. For major accounts like Costco, we offer flexible MOQs and forecast-based pre-production to ensure supply chain resilience.

How often and for how long should I use it?

It should be used 3 times per week, spaced out every other day (e.g., Monday, Wednesday, Friday).Each daily treatment session is fixed at 12 minutes.It is recommended to continue this routine for a consistent 16-week period for optimal results.

Does the device have any smart safety sensors?

Yes. It is equipped with an intelligent sensor that ensures laser emission occurs only when the helmet is properly worn on your head.

If the device is removed or if the treatment is paused, the laser will immediately deactivate.It also features an overheat protection system

What treatment modes and irradiation areas are available?

The helmet supports dual control modes (Physical Button Control and Bluetooth App Remote Control)

  • Mode Selection: The device provides a "Continuous Mode" (constant laser output) by default, and a "Pulse Mode" (intermittent laser output) which is available via the App
  • Irradiation Zones: Using the App, you can select from four specific scalp zones: Forehead, Crown, Occipital, or Full Head

What is the working principle of this hair growth helmet?

The device utilizes Low Level Laser Therapy (LLLT). It works by providing laser energy to stimulate hair follicles, promoting hair growth in both men and women

Do you offer private labeling or custom logo services?

Custom logo services (OEM/ODM) are available upon request.We provide flexible OEM services, including custom logo placement on our Laser Helmets and Laser Caps

What is the features of Laser Helmet 352

1): The market's first app-controlled smart laser helmet for hair growth.
2): FDA-cleared laser helmet for effective hair regrowth.
3): Features 352 laser diodes (650nm) with a max power of 1760mW for high-performance results.
4): Smart sensor-controlled output ensures safe, reliable operation.
5): Targeted zonal treatment modes for various hair loss patterns.
6): Built-in high-capacity lithium battery for easy use.

What is the latest hair growth laser cap?

Lascure is a premier brand of laser hair growth products under Hubei YJT Technology Co., Ltd. With a 21-year history, YJT is China’s leading manufacturer and R&D hub for advanced laser hair restoration technology. Our portfolio features a comprehensive line of laser hair restoration devices, ranging from hair growth laser combs to medical-grade laser caps and laser helmets. Our flagship model, the Laser Helmet 352, represents the pinnacle of our current technology.

Is the Laser Helmet 352 FDA-cleared

Yes,the newest laser helmet has 352pcs 650nm laser diodes and it is FDA-Cleared for Hair growth for men and women

What Happens During Laser Therapy

1.Scalp Preparation

Before the therapy session begins, the scalp is cleaned and prepared to ensure optimal treatment efficacy.

2.Positioning of the Laser Device

Wearing  Lascure Laser Cap over the scalp, targeting the areas affected by hair loss or thinning.

3.Application of Low-Level Laser Light

The Laser cap emits gentle, non-thermal, low-level laser light that penetrates the scalp's surface without causing any discomfort or burning sensation.

4.Stimulation of Hair Follicles

The low-level laser light is absorbed by the hair follicles, which then triggers a process known as photobiomodulation. This process helps increase cellular metabolism and blood flow to the hair follicles, encouraging them to enter the active growth phase.

Do you enforce a Minimum Advertised Price (MAP) policy to prevent price wars among distributors?

We suggest the retail price on the market is $1399.Furthermore, each channel has a limit on the number of agents. For example, we only allow two agents to sell this product on Amazon.

Does this design hold independent industrial design patents, and have you conducted a Freedom to Operate (FTO) analysis to ensure it does not infringe on the patents of major Western brands like HairMax or Capillus?

This product was developed by our R&D center over two years. Both the product design and the technology are our original creations. Furthermore, we have a product appearance patent certificate.

What certifications do you have?

We have got CE and FDA 510K certificate

How do you handle warranty claims? Shipping defective units back to China is too expensive?

You simply provide us with a video/photo of the issue and the serial number. We will replace the unit for free in your next order. You do not need to ship the defective unit back to China.

What is your MOQ (Minimum Order Quantity) for a private label order (Custom Logo & Packaging)?

For simple Logo printing on the device: We can start with as few as 50-100 units.

For full customization (Custom packaging box, User Manual, and Device Color): The standard MOQ is 500 units.

Is it FDA 510(k) cleared as a Class II medical device, or is it just FDA registered?

Yes, our Laser Helmet is fully FDA 510(k) cleared under the product code OAP (Laser surgical instrument for use in general and plastic surgery and in dermatology). The 510(k) number is K232356 and K230134. You can verify this directly on the FDA database. We are not just factory registered; the device itself is cleared for safety and efficacy.

What is LASCURE?

LASCURE is a sub-brand of YJT Co., specializing in the production and sales of laser hair growth products.

YJT is manufacturer or trade company?

Yes, YJT Co., is a 20 years manufacturer of low level laser therapy and High potential therapy equipment.

What Certifications do you have ?

We got ISO13485,ISO9001,MDSAP,CE,FDA,CFDA,UKCA,UL,RoHs,CFS,etc.

What is your warranty period and coverage?

Warranty is one year and lifetime after-sales service

Can you customize product?

Yes, we can support OEM and ODM service.

What is the delivery time?

Normally, stock is available;For laser logo orders, delivery time is 2 days; for OEM orders, delivery time is generally 30 days; for ODM orders, delivery time is generally 3 months.

What is your minimum order quantity (MOQ)?

MOQ can be negotiation,please send inquiry to us

What payment methods do you accept?

We accept T/T bank transfer, PayPal, Credit card and so on;Payments can be made in US Dollars, Euros, Philippine Pesos, Malaysian Ringgit, or Indonesian Rupiah. Flexible and convenient for international customers.

Can you sign NDA?

Yes,sure, we alway sign the NDA with agents for ODM product specially

Do you support third-party factory inspections?

Yes,you can arrange third-party to inspect products before shipment.

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