# K212099: Red Wave Hair Removal

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Accompany Technology Co., Ltd.
- Decided: Sep 24, 2021 after 80 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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
Longest line of descent: 19 generations back to K950019 (1995). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160968: iPulse SmoothSkin Gold Hair Removal Device, Cyden Limited (2016) Summary page 5.
- K172791: Lumilisse IPL Hair Remover, Conair Corporation (2018) Summary page 5.
- K190820: Aimanfun Lumea Comfort, Kam Yuen Plastic Products, Ltd. (2019) Summary page 5.

## Indications for use
The Red Wave Hair Removal Device is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.

Source page: https://510kreport.com/device/K212099
Methodology: https://510kreport.com/methodology