# K211977: Medical Diode Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Dimed Laser Technology Co., Ltd.
- Decided: Oct 26, 2021 after 123 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: 3 generations back to K043046 (2005). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160549: Medical Diode Laser Systems, Wuhan Gigaa Optronics Technology Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K252564: Medical Diode Laser Systems (VeinCure) (2025), 0 descendants of its own
- K252063: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (2025), 0 descendants of its own
- K231548: Medical Diode Laser, Model S1Pro (2023), 0 descendants of its own

## Indications for use
The "CHERYLAS-15N and CHERYLAS-20N" are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K211977
Methodology: https://510kreport.com/methodology