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LaserComb

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110233

by Lexington International, LLC

Identifiers

510(k) Number
K110233 FDA 510(k)
FDA Product Code
OAP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5500 FDA 510(k)
Regulation Number
890.5500 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LaserComb is a low-level laser therapy (LLLT) device designed for hair regrowth. It delivers targeted laser energy to the scalp to stimulate hair follicles, potentially improving hair density and thickness in individuals experiencing hair loss.

Supplied as a reusable, non-sterile device, the LaserComb is intended for home use. It operates within Class II laser safety standards and has received FDA 510(k) clearance under the Physical Medicine advisory committee. The device is not MRI-safe and requires no special storage conditions beyond those recommended by the manufacturer.

Frequently asked questions

Is the LaserComb designed for professional use in clinics or is it meant for home use by individuals?

The LaserComb is explicitly designed for home use by individuals experiencing hair loss. It is supplied as a reusable device and does not require clinical supervision or professional administration.

How is the LaserComb sterilized or cleaned, and is it intended for single-use or reuse?

The LaserComb is a reusable, non-sterile device. Since it is not sterile, it must be cleaned according to the manufacturer’s instructions between uses to maintain hygiene and functionality. It is not intended for single-use.

What safety precautions should be taken when using the LaserComb, particularly regarding laser exposure?

The LaserComb operates within Class II laser safety standards, which means it emits low-level laser energy designed for safe home use. However, users should follow the manufacturer’s guidelines to avoid direct exposure to eyes or skin, especially during operation, to prevent potential harm.

Are there specific storage requirements for the LaserComb beyond standard room conditions?

No special storage conditions are required for the LaserComb beyond those recommended by the manufacturer. It does not need refrigeration, humidity control, or any other specialized environment, making it convenient for home use.

What is the regulatory pathway for the LaserComb, and how was its safety and effectiveness determined?

The LaserComb received FDA 510(k) clearance under the Physical Medicine advisory committee, indicating it was determined to be substantially equivalent to a legally marketed device. This clearance process involved demonstrating that its design and intended use meet applicable safety and performance standards for low-level laser therapy devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hairmax® | Hair Regrowth Laser Treatments for Hair Loss, HairMax LaserComb LLLT Hair Loss | Bernstein Medical, Lexington International Company Profile -Sales, Contacts, Competitors ..., HairMax Laser Comb - 4 Hair Loss

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lexington International, LLC

Sources (1)

  • FDA 510(k) K110233 24 fields · synced Sep 19, 2026