# K173729: Revian Red

- Pathway: 510(k) (Traditional)
- Applicant: Photonmd, Inc.
- Decided: Feb 28, 2018 after 84 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: 8 generations back to K001179 (2000). 22 ancestors in all.
19 later devices descend from it; 9 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162782: iHelmet Hair Growth System, Slinph Technologies Co., Ltd. (2017) Summary page 4.
- K152019: HairMD, Trophy Skin, Inc. (2015) Summary page 4.
- K142573: HairMax LaserComb, HairMax LaserComb, Lexington International, LLC (2014) Summary page 4.
- K122950: Laser Helmet, Theradome, Inc. (2013) Summary page 4.

## Most influential descendants
- K211038: Biophotas Celluma RESTORE (2021), 9 descendants of its own
- K193008: Tricoglam Home Use (2020), 6 descendants of its own
- K213025: Laser hair growth helmet (2022), 5 descendants of its own
- K242363: HIGHERDOSE Red Light Hat (HG-120K) (2024), 4 descendants of its own
- K230336: CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07) (2023), 3 descendants of its own

## Indications for use
REVIAN RED is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

Source page: https://510kreport.com/device/K173729
Methodology: https://510kreport.com/methodology