# K160728: NutraStim Hair Laser Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Nutra Luxe MD, LLC
- Decided: Sep 16, 2016 after 184 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: 7 generations back to K001179 (2000). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132646: Sunetics Clinical Bio-Stimulation Laser, Sunetics International Marketing Group, LLC (2013) Summary page 4.
- K142573: HairMax LaserComb, HairMax LaserComb, Lexington International, LLC (2014) Summary page 4.

## Most influential descendants
- K182501: Hair Laser Headband (2018), 0 descendants of its own

## Indications for use
NutraStim Hair Laser Helmet is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of 11a to V patters of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4, 11-1, 11-2, or frontal, both with Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K160728
Methodology: https://510kreport.com/methodology