# K122248: Igrow II Hair Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Apira Science, Inc.
- Decided: Dec 5, 2012 after 131 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.
80 later devices descend from it; 4 cite it directly.
0 of 81 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) Hairmax Lasercomb: named in the summary without a submission number

## Most influential descendants
- K140931: Igrow II Hair Growth System (2014), 76 descendants of its own
- K160285: Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 (2016), 59 descendants of its own
- K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 (2017), 51 descendants of its own
- K162071: IllumiFlow Laser Cap (2017), 35 descendants of its own
- K162782: iHelmet Hair Growth System (2017), 22 descendants of its own

## Indications for use
The igrow-Il Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K122248
Methodology: https://510kreport.com/methodology