# K961748: Medlite/Erbium Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Biomedical, Inc.
- Decided: Jul 26, 1996 after 81 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 K954013 (1996). 1 ancestor in all.
1,230 later devices descend from it; 10 cite it directly.
0 of 1,232 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 1.

## Most influential descendants
- K972347: Modified Coherent Versapulse Aesthetic Surgical Laser (1997), 1,142 descendants of its own
- K001589: Candela Dynamic Cooling Device (2000), 1,064 descendants of its own
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), 1,046 descendants of its own
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems (2003), 856 descendants of its own
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems (2003), 756 descendants of its own

## Indications for use
For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

Source page: https://510kreport.com/device/K961748
Methodology: https://510kreport.com/methodology