# K060305: Hairmax Lasercomb

- Pathway: 510(k) (Traditional)
- Applicant: Lexington International, LLC
- Decided: Jan 18, 2007 after 346 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
No predicates in its family tree.
93 later devices descend from it; 3 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Robi Combi: named in the summary without a submission number
- (no number) DermaLight Psoracomb: named in the summary without a submission number
- (no number) Quantum WARP 10 Light Delivery System: named in the summary without a submission number
- (no number) Lumiphase-R: named in the summary without a submission number
- (no number) TerraQuant MQ2000 Laser Therapy Device: named in the summary without a submission number
- (no number) MLT R694 Ruby Laser System: named in the summary without a submission number
- (no number) L600 Hair Removal: named in the summary without a submission number
- (no number) Violet Ray Device: named in the summary without a submission number
- (no number) Vacuum Cap: named in the summary without a submission number
- (no number) Raydo and Wonder Brush: named in the summary without a submission number

## Most influential descendants
- K093499: Hairmax Lasercomb (2009), 82 descendants of its own
- K103368: Hairmax Lasercomb (2011), 81 descendants of its own
- K142573: HairMax LaserComb, HairMax LaserComb (2014), 73 descendants of its own
- K160285: Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 (2016), 59 descendants of its own
- K091496: Mep-90 Hair Growth Stimulation System (2010), 58 descendants of its own

## Indications for use
The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K060305
Methodology: https://510kreport.com/methodology