# K141567: Igrow - II Hair Growth System, Igrow Hair Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Apira Science, Inc.
- Decided: Aug 21, 2014 after 70 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.
63 later devices descend from it; 5 cite it directly.
0 of 64 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
- K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 (2017), 51 descendants of its own
- K162782: iHelmet Hair Growth System (2017), 22 descendants of its own
- K152019: HairMD (2015), 22 descendants of its own
- K173729: Revian Red (2018), 19 descendants of its own
- K173678: Diode Laser Cap (2018), 16 descendants of its own

## Indications for use
The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of I1a-V and Fitzpatrick Classification of Skin Phototypes of I-IV

Source page: https://510kreport.com/device/K141567
Methodology: https://510kreport.com/methodology