# K140931: Igrow II Hair Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Apira Science, Inc.
- Decided: Dec 5, 2014 after 238 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: 1 generation back to K122248 (2012). 1 ancestor in all.
76 later devices descend from it; 7 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122248: Igrow II Hair Growth System, Apira Science, Inc. (2012) Summary page 8.
- (no number) Hairmax Lasercomb: named in the summary without a submission number

## Most influential descendants
- 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
- K152019: HairMD (2015), 22 descendants of its own

## Indications for use
The igrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K140931
Methodology: https://510kreport.com/methodology