# K895518: Coherent Holmium:Yag Surgical Laser

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Nov 30, 1989 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.
352 later devices descend from it; 2 cite it directly.
0 of 353 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
- K980685: Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers (1998), 351 descendants of its own
- K990947: Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and  Delivery (1999), 350 descendants of its own
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices (2001), 342 descendants of its own
- K083616: Patholase Family of Pinpointe and Pinpointe  Footlaser ND: Yag Lasers (2009), 136 descendants of its own
- K083215: Incisive Family of Inpulse ND:Yag Lasers (2009), 136 descendants of its own

Source page: https://510kreport.com/device/K895518
Methodology: https://510kreport.com/methodology