# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Dimed Laser Technology Co., Ltd.
- Decided: Sep 25, 2025 after 86 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: 21 generations back to K943450 (1995). 458 ancestors in all.
No later device cites it as a predicate yet.
0 of 459 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211977: Medical Diode Laser Systems, Wuhan Dimed Laser Technology Co., Ltd. (2021) Summary page 5.
- K151890: Medical Diode Laser Systems, Wuhan Gigaa Optronics Technology Co., Ltd. (2015) Summary page 6.

## Indications for use
The BERYLAS-12N and the BERYLAS-15N are indicated for the treatment of reflux of the saphenous veins associated with varicose verins and varicosities. 1470nm:Indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. 980nm:Indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (UJrology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology Endovascular coagulation, Oral Surgery and Dental procedures, laser assisted lipolysis.

Source page: https://510kreport.com/device/K252063
Methodology: https://510kreport.com/methodology