# K222800: Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)

- Pathway: 510(k) (Traditional)
- Applicant: Sanhe Laserconn Tech Co., Ltd.
- Decided: Nov 7, 2022 after 52 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). 520 ancestors in all.
No later device cites it as a predicate yet.
0 of 521 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 4.
- K210168: Diode Laser Therapy Systems, Beijing Kes Biology Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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.

Source page: https://510kreport.com/device/K222800
Methodology: https://510kreport.com/methodology