# K960475: Modified Luxar LX-20 Family CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Luxar Corp.
- Decided: Apr 26, 1996 after 85 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 K953074 (1995). 1 ancestor in all.
403 later devices descend from it; 8 cite it directly.
0 of 405 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953074: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1995) Summary page 1.

## Most influential descendants
- K991628: Modified LX-20 CO2 Laser System Family, LX-20SA (1999), 377 descendants of its own
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (2002), 376 descendants of its own
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers (2003), 323 descendants of its own
- K031795: Reliant Laser System (2003), 318 descendants of its own
- K040617: Reliant Laser System II (2004), 316 descendants of its own

## Indications for use
The intended use of the modified LX-20 is identical to that of the LX-20, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of: Gynecology Laparoscopic Surgery including GYN laparoscopy Dermatology Dental and oral surgery Orthopedic General Surgery Otorhinolaryngology Podiatry

Source page: https://510kreport.com/device/K960475
Methodology: https://510kreport.com/methodology