# K980685: Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: May 20, 1998 after 86 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: 2 generations back to K902990 (1990). 10 ancestors in all.
351 later devices descend from it; 1 cites it directly.
0 of 362 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960413: Coherent Slimline Single Lumen Aspiration Needle Kit, Lumenis, Inc. (1996) Summary page 1.
- K933318: Coherent Versapulse 2.1U /1.06U Compact Surgical Laser, Models a & B, Lumenis, Inc. (1994) Summary page 1.
- K932981: Coherent Versapulse 2.1 Holmium Surgical Lasers, Coherent Medical Group (1994) Summary page 1.
- K923575: Coherent Versapluse 2.1 Holmium Surg. Lasers, Coherent Medical Group (1993) Summary page 1.
- K914991: Versapulse (TM) Twopointone/XE Holmium Surg Lasers, Coherent Medical Group (1992) Summary page 1.
- K914136: Coherent Versapulse (TM) 2.1XE/2.1L Holmi Surg Lase, Coherent Medical Group (1992) Summary page 1.
- K910037: Coherent Holmium:Yag Surgical Laser, Coherent Medical Group (1991) Summary page 1.
- K902990: Coherent Holmium:Yag Surgical Laser, Coherent Medical Division (1990) Summary page 1.
- K895518: Coherent Holmium:Yag Surgical Laser, Lumenis, Inc. (1989) Summary page 1.

## Most influential descendants
- 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
- K093545: Pinpointe Footlaser Model 6W, 30W, 100W (2010), 122 descendants of its own

## Indications for use
The modified and the currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are intended for use in endoscopic holmium laser resection of the prostate (HoLRP) for treatment of benign prostatic hypertrophy (BPH).

Source page: https://510kreport.com/device/K980685
Methodology: https://510kreport.com/methodology