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Hair Boom 69 Laser Comb

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182562

by Wontech

Identifiers

510(k) Number
K182562 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 Hair Boom 69 Laser Comb is a low-level laser therapy (LLLT) device designed as a helmet-integrated comb for hair growth promotion. It employs diode lasers to deliver targeted light therapy to the upper third of the scalp, targeting areas typically associated with hair styling and growth stimulation.

This device is intended for home use and is supplied as a reusable, non-sterile medical device. It operates within Class II regulatory classification under FDA 510(k) clearance (K182562) and is intended for physical medicine applications. No MRI safety information or additional sterility requirements are specified.

Frequently asked questions

Is the Hair Boom 69 designed for professional use in clinics or for home use by patients?

The Hair Boom 69 is explicitly designed for home use as a reusable, non-sterile device. It is not intended for clinical or professional settings, though it is classified under FDA’s Physical Medicine category for regulatory purposes.

How is the Hair Boom 69 different from other laser combs, and what makes it unique?

The Hair Boom 69 integrates diode lasers into a helmet-style comb design, targeting the upper third of the scalp—a specific area for hair growth promotion. Unlike traditional combs, it delivers low-level laser therapy (LLLT) to stimulate hair follicles, making it distinct from non-laser styling tools.

Can the Hair Boom 69 be reused, or is it meant for single-use only?

The device is reusable and explicitly labeled as non-sterile, meaning it is intended for repeated use by the same individual at home. No sterility requirements are specified, so cleaning and maintenance per manufacturer guidelines are recommended.

What regulatory pathway did the Hair Boom 69 follow to gain market authorization?

The Hair Boom 69 received FDA 510(k) clearance (K182562) under the Traditional 510(k) Review pathway, classified as Substantially Equivalent to a predicate device. It falls under Class II regulatory classification and was reviewed by the Physical Medicine (PM) Advisory Committee.

Are there any special storage requirements for the Hair Boom 69?

The device data does not specify special storage conditions beyond standard handling for a reusable, non-sterile medical device. However, since it is designed for home use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain functionality.

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: K223862 FDA 510 (k) - Hair Boom 69 | Wontech Co., Ltd., K182562 - Hair Boom 69 | FDA 510(k) | Wontech, PDF 510(k) Summary - Food and Drug Administration, Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp, Hair Boom 69, Hair Boom Air, Ulike Hair UpUp (K192425) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wontech

Sources (1)

  • FDA 510(k) K182562 24 fields · synced Sep 19, 2026