# K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Jul 7, 1995 after 79 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
No predicates in its family tree.
1,418 later devices descend from it; 9 cite it directly.
0 of 1,419 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960032: Coherent Versapulse Aesthetic Surgical Lasers (1996), 1,152 descendants of its own
- 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

Source page: https://510kreport.com/device/K951812
Methodology: https://510kreport.com/methodology