# K183329: Laser Hair Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Omm Imports, Inc. D/B/A Zero Gravity
- Decided: Jan 16, 2019 after 47 days
- Product code: OAP (Laser, Comb, Hair)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K060305 (2007). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142573: HairMax LaserComb, HairMax LaserComb, Lexington International, LLC (2014) Summary page 4.
- K141596: Nutra Stim Hair Laser Comb, Nutra Luxe MD, LLC (2015) Summary page 4.
- K141588: Nutra Stim Hair Laser Comb, Nutra Luxe MD, LLC (2015) Summary page 4.

## Most influential descendants
- K213789: Intelligence LaserComb (2022), 1 descendant of its own
- K252053: VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) (2025), 0 descendants of its own
- K202631: iHelmet Laser Comb (2020), 0 descendants of its own

## Recalls of this device
- Sep 1, 2022 · Class II · Z-1222-2023: 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 

## Indications for use
Laser Hair Therapy is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.

Source page: https://510kreport.com/device/K183329
Methodology: https://510kreport.com/methodology