# K123483: Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Syntech Laser CO., LTD.
- Decided: Apr 21, 2013 after 159 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). 59 ancestors in all.
53 later devices descend from it; 6 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application, Alma Lasers, Inc. (2011) Summary page 4.

## Most influential descendants
- K141973: Diode Laser Hair Removal System (2014), 48 descendants of its own
- K162659: Diode Laser Hair Removal System (2017), 40 descendants of its own
- K180353: Diode laser hair removal device (2018), 24 descendants of its own
- K210663: Dermatological Diode Laser Systems (2021), 8 descendants of its own
- K181019: Diode Laser System (2018), 6 descendants of its own

## Indications for use
The Diode Laser is intended for use in dermatologic and general surgical procedures. The Standard Mode is intended for hair removal, permanent hair reduction. The FHR Mode is intended for hair removal, permanent hair reduction. The diode laser system is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Source page: https://510kreport.com/device/K123483
Methodology: https://510kreport.com/methodology