# K211038: Biophotas Celluma RESTORE

- Pathway: 510(k) (Traditional)
- Applicant: Biophotas, Inc.
- Decided: Jun 29, 2021 after 83 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.
9 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173729: Revian Red, Photonmd, Inc. (2018) Summary page 7.
- K162782: iHelmet Hair Growth System, Slinph Technologies Co., Ltd. (2017) Summary page 7.

## Most influential descendants
- K242363: HIGHERDOSE Red Light Hat (HG-120K) (2024), 4 descendants of its own
- K230597: Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) (2023), 2 descendants of its own
- K253669: Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300) (2026), 1 descendant of its own
- K262183: Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) (2026), 0 descendants of its own
- K261675: CHZL Red Light Therapy Hair Growth Cap (Model (s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K211038
Methodology: https://510kreport.com/methodology