Lascure Hair Growth Laser Helmet 552 Receives FDA 510(k) Clearance
Jul 13,2026
We are excited to announce that the **Lascure Laser Hair Growth Helmet** has been granted **U.S. FDA 510(k) Clearance K253231**, underscoring our dedication to creating safe, effective, and high-quality laser hair restoration products. This FDA clearance applies to our newest laser hair growth system, including the **Laser Helmet 552, Laser Helmet 500, Laser Helmet 352, Laser Helmet 272 and Laser Cap 128**, confirming that it complies with regulatory standards for its intended use. ([FDA Access Data]
Designed for people dealing with androgenetic alopecia, the Lascure Laser Helmet 552 features
**300 medical-grade 655 nm laser diodes** and **200 LEDs**, totaling **552 light sources** to ensure thorough scalp coverage. Its ergonomic helmet design offers comfortable wear, and an intelligent safety sensor activates treatment only when the helmet is properly positioned.
Additional benefits include four treatment modes targeting specific scalp areas, a rechargeable battery, and an automatic treatment timer for easy home use.
Compared to traditional laser combs, the Laser Helmet 552 provides **hands-free operation, broader treatment coverage, enhanced comfort, and more consistent results**, making it easier for users to stick to their treatment regimen. Utilizing clinically validated **Low-Level Laser Therapy (LLLT)** technology, it offers a non-invasive, drug-free method to stimulate hair growth.
Receiving FDA 510(k) Clearance represents a significant achievement for Lascure as we continue to offer innovative laser therapy devices trusted by distributors, healthcare professionals, and consumers around the globe.
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