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 |
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| Energy Density 6.372 J/cm² |
Head Circumference 51–61 cm (20.08–24.02 in) |
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| Laser Classification Class 3R |
80 × Medical-Grade VCSEL Lasers
Powered by 80 VCSEL laser diodes at 650nm ±10nm, delivering focused optical energy without an LED mixed-light matrix.
One-Touch Daily Treatment
Simple one-button control allows users to start a complete 30-minute treatment session without complicated setup.
3,800mAh Rechargeable Battery
Built-in lithium battery supports cordless treatment sessions without restricting users with external cables.
Only 484g
A lightweight ergonomic dome design supports comfortable home use and easy integration into everyday treatment routines.
Built for Scalable Private Label
Support logo customization, packaging, localized manuals and broader OEM/ODM solutions for hair-growth brands and distributors.
FDA-Cleared Platform
FDA 510(k) cleared under K232356 and developed in ISO 13485 certified manufacturing facilities.
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.
✓ 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).
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.
Hair-Growth Support
Designed for eligible male and female users as part of an established home-use hair-growth program.
Androgenetic Alopecia
Intended for androgenetic alopecia applications within the user groups and conditions covered by the cleared indication.
Fuller-Looking Hair
Designed to support an ongoing hair-care routine for users seeking healthier and fuller-looking hair.
Home-Use Maintenance
Cordless one-touch operation supports convenient integration into a regular at-home hair-care routine.
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.
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.
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.
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.
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.
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.
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Customized Laser Comb Color
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Original
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Black
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Black&red
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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.
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Customized Laser Comb Color
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Original
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Black
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Black&red
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White &red
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ODM Customization Service
PRODUCT DEVELOPMENT PROCESS
From Concept To Production
A complete product development pathway from feasibility evaluation to mass manufacturing.

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.


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.

SUPPORT & INFORMATION
Frequently Asked Questions
Company Certifications
FDA Certificate
510K K253231
Issue by FDA
FDA Certificate
510K:K230134
Issue by FDA
FDA Certificate
510K:k232356
Issue by FDA
ISO9001
Number:CN23/00005469
Issued by SGS
ISO 13485
Number:No,Q5 122071
Issued by TUV
Medical CE
Number No.:0120
Issue by SGS
CFS
Number No.20240187
Issue by CFDA
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
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
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.
More Products
Lascure provides full OEM and ODM services, enabling product customization to meet various brand identities and requirements.
Customer service hotline:+86 186-7402-3730
Service time:8:00 - 17:00





