# K171835: Irradiation Aesthetic Device

- Pathway: 510(k) (Traditional)
- Applicant: Chongqing Peninsula Medical Technology Co., Ltd.
- Decided: Jan 30, 2018 after 224 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: 7 generations back to K001179 (2000). 19 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352, Capillus, LLC (2017) Summary page 5.
- K160285: Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202, Capillus, LLC (2016) Summary page 5.
- K153618: Capillus202, Capillus, LLC (2016) Summary page 5.

## Most influential descendants
- K192552: Irradiation Cosmetic Device (2020), 2 descendants of its own
- K231321: Nooance Led And Laser Helmet (2023), 1 descendant of its own
- K192627: Laser Hair Growth Cap (2019), 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
- K261253: Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5) (2026), 0 descendants of its own

## Indications for use
The Irradiation Aesthetic Device (Model: HairPro) 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/K171835
Methodology: https://510kreport.com/methodology