# K242619: GroWell BT Hair Growth System (GW10042)

- Pathway: 510(k) (Traditional)
- Applicant: Apira Science, Inc.
- Decided: Dec 2, 2024 after 90 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: 9 generations back to K001179 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140931: Igrow II Hair Growth System, Apira Science, Inc. (2014) Summary page 5.
- K141567: Igrow - II Hair Growth System, Igrow Hair Growth System, Apira Science, Inc. (2014) Summary page 5.
- K173729: Revian Red, Photonmd, Inc. (2018) Summary page 5.

## Indications for use
MEN - The GroWell BT Hair Growth System ("GroWell") is designed to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V. WOMEN - The GroWell is designed to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin classifications of I-II. The GroWell is approved for Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K242619
Methodology: https://510kreport.com/methodology