# K121920: Laserbrush

- Pathway: 510(k) (Traditional)
- Applicant: Sunetics International Marketing Group, LLC
- Decided: Jun 27, 2013 after 360 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110233: Hairmax Lasercomb, Lexington International, LLC (2011) Summary page 1.
- K103368: Hairmax Lasercomb, Lexington International, LLC (2011) Summary page 1.
- K112524: Hairmax Lasercomb, Lexington International, LLC (2011) Summary page 1.

## Most influential descendants
- K170068: Softcure 96 (2017), 0 descendants of its own

## Indications for use
The Sunetics LaserBrush is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV. The Sunetics LaserBrush is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K121920
Methodology: https://510kreport.com/methodology