# K203271: Aduro light therapy Handheld

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical CO, Ltd.
- Decided: Jul 21, 2021 after 257 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own
- K210545: Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine (2022), 2 descendants of its own
- K250761: KALA Therapy Wand (Model: KALA-03) (2025), 1 descendant of its own
- K242151: Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) (2025), 1 descendant of its own
- K253833: Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) (2026), 0 descendants of its own

## Indications for use
The Aduro light therapy Handheld (Model:HD-03A,HD-25A,HD-07A), the red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K203271
Methodology: https://510kreport.com/methodology