# K060304: Photex Diode Laser Series, Models 980, 810 and 940

- Pathway: 510(k) (Traditional)
- Applicant: Biotex, Inc.
- Decided: Mar 21, 2006 after 43 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: 1 generation back to K952661 (1995). 1 ancestor in all.
42 later devices descend from it; 5 cite it directly.
2 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952661: SLT Thermalite Diode Laser Series, Diode 980, 810, 940, Surgical Laser Technologies, Inc. (1995) Summary page 1.
- (no number) PhotoMedex LaserPro Diode Laser Systems: named in the summary without a submission number

## Most influential descendants
- K071328: Visualase Thermal Therapy System (2007), 26 descendants of its own
- K081509: Monteris Medical Autolitt Laser Probe (2009), 22 descendants of its own
- K120561: Neuroblate System (2013), 21 descendants of its own
- K131955: Neuroblate (TM) System (2013), 19 descendants of its own
- K131278: Monteris Medical Neuroblate System (2013), 19 descendants of its own

## Indications for use
The PhoTexl 5 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/K060304
Methodology: https://510kreport.com/methodology