# K230597: Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)

- Pathway: 510(k) (Traditional)
- Applicant: Light Tree Ventures Europe B.V.
- Decided: Apr 28, 2023 after 56 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: 10 generations back to K001179 (2000). 24 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211038: Biophotas Celluma RESTORE, Biophotas, Inc. (2021) Summary page 4.

## Most influential descendants
- K252053: VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) (2025), 0 descendants of its own
- K241342: Hair Growth Comb (SZ-23,SZ-23A) (2024), 0 descendants of its own

## Indications for use
The Aduro Comb (Model: SZ-22A) 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/K230597
Methodology: https://510kreport.com/methodology