# K230580: Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Smedtrum Medical Technology Co., Ltd.
- Decided: May 26, 2023 after 85 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.
No later device cites it as a predicate yet.
0 of 567 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) Summary page 4.

## Indications for use
The Diode Laser System includes 2 types of handpieces with same 1.2 x 1.4 cm spot size: Single-Wavelength Handpiece 810nm wavelength The 810nm wavelength handpiece is 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 I-VI), including tanned skin.(HR, and FHR Modes) Trio-Wavelength Handpiece The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR).

Source page: https://510kreport.com/device/K230580
Methodology: https://510kreport.com/methodology