# K232117: Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Lotuxs Technology Co., Ltd.
- Decided: Nov 28, 2023 after 134 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: 11 generations back to K910422 (1992). 106 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133319: ET Lightsheer 1060, High Speed Lightsheer 1060, Lumenis, Ltd. (2014) Summary page 4.
- K141425: Elite + Laser System, Cynosure, Inc. (2014) Summary page 4.

## Most influential descendants
- K231910: DermRays Revive (2024), 0 descendants of its own

## Indications for use
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction. Permanent hair reduction is 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. Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

Source page: https://510kreport.com/device/K232117
Methodology: https://510kreport.com/methodology