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Laser Hair Therapy

by Omm Imports, Inc. D/B/A Zero Gravity

510(k) K183329

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183329 Date16 Jan 2019ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1222-2023 FDA Class II initiated 1 Sep 2022

    The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information, reproductions and locations of the labels, and a warning statement in the user manual.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OAP
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Laser Hair Therapy is a comb-shaped low level laser therapy device that emits laser light to promote hair growth. It provides distributed laser to the scalp at 655+/-5nm while the comb teeth part the user's hair to ensure the laser light reaches the scalp.

The device is supplied as a single unit and is intended for use in physical medicine. It has received FDA 510(k) clearance under approval number K183329 and is classified under regulation number 890.5500 with product code OAP.

Other devices from Omm Imports, Inc. D/B/A Zero Gravity

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Laser Hair Therapy device used for?

    The Laser Hair Therapy device is used to promote hair growth by emitting low level laser light to the scalp.

  • Is the Laser Hair Therapy device supplied as a single unit or in multiple parts?

    The Laser Hair Therapy device is supplied as a single unit.

  • What is the wavelength of the laser light emitted by the Laser Hair Therapy device?

    The Laser Hair Therapy device emits laser light at a wavelength of 655+/-5nm.

  • Has the Laser Hair Therapy device received FDA clearance?

    Yes, the Laser Hair Therapy device has received FDA 510(k) clearance under approval number K183329.