# K193446: Bare: 808

- Pathway: 510(k) (Traditional)
- Applicant: Luvo Medical Technologies, Inc.
- Decided: Mar 10, 2020 after 89 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: 20 generations back to K943450 (1995). 515 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 518 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform, Alma Lasers, Ltd. (2014) Summary page 5.

## Most influential descendants
- K203728: Darwin (2021), 1 descendant of its own
- K212607: Darwin (2021), 0 descendants of its own

## Indications for use
The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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 I-VI) including tanned skin

Source page: https://510kreport.com/device/K193446
Methodology: https://510kreport.com/methodology