# K222862: SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC

- Pathway: 510(k) (Traditional)
- Applicant: Lotuxs Medtech (Suzhou) Co., Ltd.
- Decided: Jul 30, 2023 after 311 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 25 generations back to K943450 (1995). 566 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 568 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222064: The Alma Soprano Titanium, Alma Lasers, Inc. (2022). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K242859: VEGA (2025), 0 descendants of its own

## Indications for use
The indications for use for the SILKPRO-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the SILKPRO-S20S-755A include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a 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 regimen. Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes) The indications for use for the SILKPRO-S20S-81OB include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number ofairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

Source page: https://510kreport.com/device/K222862
Methodology: https://510kreport.com/methodology