# K100228: Versapulse Model P20 Laser System

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Inc.
- Decided: Feb 24, 2010 after 29 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: 6 generations back to K936109 (1994). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) Summary page 2.

## Most influential descendants
- K130344: Dornier Medilas Uropulse (2013), 0 descendants of its own

## Indications for use
The VersaPulse P20 Ho:YAG (2.1 µm wavelength) is indicated for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: * Arthroscopy * Urology * Urinary lithotripsy * ENT surgery * Gynecological surgery * General surgery * Gastroenterological surgery

Source page: https://510kreport.com/device/K100228
Methodology: https://510kreport.com/methodology