# K163173: Handheld Diode Laser for Hair Removal

- Pathway: 510(k) (Traditional)
- Applicant: Liaoning Sidey Optoelectronics Technologies Co., Ltd.
- Decided: Feb 8, 2017 after 86 days
- Product code: OHT (Light Based Over-The-Counter Hair Removal)
- 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: 12 generations back to K950019 (1995). 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)
- K120737: Tria Laser Hair Removal System, Tria Beauty, Inc. (2012) Summary page 6.
- K142845: SILKPRO laser hair removal system, Wuhan Lotuxs Technology Co., Ltd. (2015) Summary page 6.

## Indications for use
The Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.

Source page: https://510kreport.com/device/K163173
Methodology: https://510kreport.com/methodology