# K132989: Speed 808 Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Toplaser Technology Co., Ltd.
- Decided: Jan 23, 2014 after 121 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: 10 generations back to K910422 (1992). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms, Alma Lasers, Inc. (2010) Summary page 1.

## Indications for use
The new device Speed 808 Diode Laser System is intended for use in dermatologic and general surgical procedures. The Speed 808 Diode Laser System is indicated for hair removal, permanent hair reduction. The 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 regimen. The Speed 808 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/K132989
Methodology: https://510kreport.com/methodology