# K132646: Sunetics Clinical Bio-Stimulation Laser

- Pathway: 510(k) (Traditional)
- Applicant: Sunetics International Marketing Group, LLC
- Decided: Dec 20, 2013 after 116 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: 6 generations back to K001179 (2000). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091496: Mep-90 Hair Growth Stimulation System, Midwest Rf, LLC (2010) Summary page 1.
- K122248: Igrow II Hair Growth System, Apira Science, Inc. (2012) Summary page 1.
- K122950: Laser Helmet, Theradome, Inc. (2013) Summary page 1.
- K113097: Laser Helmet, Theradome, Inc. (2012) Summary page 1.

## Most influential descendants
- K160728: NutraStim Hair Laser Helmet (2016), 1 descendant of its own
- K190685: Hair Growth System (2019), 0 descendants of its own
- K182501: Hair Laser Headband (2018), 0 descendants of its own

## Indications for use
The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Males who have Norwood Hamilton Classifications of Ila to V and Fitzpatrick Skin Types I to IV. The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Females who have Ludwig (Savin) l-4, 11-1, 11-2, or frontal patterns of hair loss and Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K132646
Methodology: https://510kreport.com/methodology