# K092197: PHOTEX30 Diode Laser Series: 980, 810, 940

- Pathway: 510(k) (Traditional)
- Applicant: Biotex, Inc.
- Decided: Oct 6, 2009 after 77 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: 2 generations back to K952661 (1995). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060304: Photex Diode Laser Series, Models 980, 810 and 940, Biotex, Inc. (2006) Summary page 1.
- K952661: SLT Thermalite Diode Laser Series, Diode 980, 810, 940, Surgical Laser Technologies, Inc. (1995) Summary page 1.

## Most influential descendants
- K142216: Tranberg CLS Thermal Therapy System (2015), 1 descendant of its own
- K201687: Avenda Health Treatment System (2020), 0 descendants of its own

## Indications for use
The PhoTex3O Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Source page: https://510kreport.com/device/K092197
Methodology: https://510kreport.com/methodology