# K241342: Hair Growth Comb (SZ-23,SZ-23A)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Nuon Medical Equipment Co., Ltd.
- Decided: Nov 8, 2024 after 179 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: 11 generations back to K001179 (2000). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230597: Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B), Light Tree Ventures Europe B.V. (2023). Our reading of the summary gave K230579, FDA’s number for Smart Wedge algorithm (Edwards Lifesciences, LLC). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Aduro Comb”.
- K211038: Biophotas Celluma RESTORE, Biophotas, Inc. (2021) Summary page 5.
- K222477: Hair Growth Device, Dongguan Lescolton Medical Equipment Co., Ltd. (2022) Summary page 6.

## Indications for use
The Hair Growth Comb (Model: SZ-23 ,SZ-23A,) 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 1-1 to 1-4, 11-1, 11-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

Source page: https://510kreport.com/device/K241342
Methodology: https://510kreport.com/methodology