# K141596: Nutra Stim Hair Laser Comb

- Pathway: 510(k) (Traditional)
- Applicant: Nutra Luxe MD, LLC
- Decided: Jan 8, 2015 after 209 days
- Product code: OAP (Laser, Comb, Hair)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K060305 (2007). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103368: Hairmax Lasercomb, Lexington International, LLC (2011) Summary page 4.

## Most influential descendants
- K183329: Laser Hair Therapy (2019), 3 descendants of its own
- 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

## Indications for use
The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K141596
Methodology: https://510kreport.com/methodology