# K192552: Irradiation Cosmetic Device

- Pathway: 510(k) (Traditional)
- Applicant: Chongqing Peninsula Medical Technology Co., Ltd.
- Decided: Apr 17, 2020 after 213 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). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171835: Irradiation Aesthetic Device, Chongqing Peninsula Medical Technology Co., Ltd. (2018) Summary page 5.
- K153618: Capillus202, Capillus, LLC (2016) Summary page 5.
- K160285: Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202, Capillus, LLC (2016) Summary page 7.

## Most influential descendants
- K231321: Nooance Led And Laser Helmet (2023), 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

## Indications for use
The Irradiation Cosmetic Device (Model: HairPro Plus) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV

Source page: https://510kreport.com/device/K192552
Methodology: https://510kreport.com/methodology