# K142845: SILKPRO laser hair removal system

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Lotuxs Technology Co., Ltd.
- Decided: Jul 1, 2015 after 274 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: 11 generations back to K950019 (1995). 28 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090820: Tria Hair Removal Laser System, Spectragenics, Inc. (2009) Summary page 6.

## Most influential descendants
- K181019: Diode Laser System (2018), 6 descendants of its own
- K200525: Medical Diode Laser Hair Removal System (2020), 1 descendant of its own
- K192569: Diode Laser Therapy System (2019), 1 descendant of its own
- K192516: Diode Laser 808nm (2019), 1 descendant of its own
- K241860: Diode Laser Hair Removal System (2024), 0 descendants of its own

## Indications for use
SILKPRO is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. SILKPRO is also intended for permanent hair reduction defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K142845
Methodology: https://510kreport.com/methodology