# K212734: Diode laser therapy device

- Pathway: 510(k) (Traditional)
- Applicant: Triangel Rsd Limited
- Decided: Jun 6, 2023 after 645 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: 16 generations back to K943450 (1995). 327 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 333 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081015: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 5.
- K073063: 15W Ceralas D 1470NM Diode Laser, Biolitec, Inc. (2008) Summary page 5.

## Most influential descendants
- K252658: Medical Diode Laser Systems (TR-B) (2025), 1 descendant of its own
- K262426: Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) (2026), 0 descendants of its own
- K250261: Heager Medical Laser Family (Sabrina/Adolf) (2025), 0 descendants of its own
- K243037: Diode Laser System model Dawn-S (2024), 0 descendants of its own
- K241771: Liftendo; Liftendo 2.0 (2024), 0 descendants of its own

## Indications for use
The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device’s 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device’s 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K212734
Methodology: https://510kreport.com/methodology