# K201687: Avenda Health Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Avenda Health, Inc.
- Decided: Nov 30, 2020 after 161 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: 4 generations back to K952661 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142216: Tranberg CLS Thermal Therapy System, Clinical Laserthermia Systems, AB (2015) Summary page 5.

## Indications for use
The Avenda Health Treatment System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardia! sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 980nm.

Source page: https://510kreport.com/device/K201687
Methodology: https://510kreport.com/methodology