# K020673: Wave Form Manufacturing Prolase General Shaped Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Wave Form Mfg., Inc.
- Decided: May 30, 2002 after 90 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: 5 generations back to K936109 (1994). 26 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954904: Microquartz Medical General Shape Laser Fiber, Microquartz Medical, Inc. (1996) Summary page 1.
- K994010: Innovaquartz General Shape Laser Fiber, Innovaquartz (1999) Summary page 1.
- K001243: Dornier Medilas H, Dornier Surgical Products, Inc. (2000) Summary page 1.
- K990947: Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and  Delivery, Lumenis, Inc. (1999) Summary page 1.

## Most influential descendants
- K022338: Optical Integrity General Shaped Fiber (2002), 1 descendant of its own
- K100194: Optical Integrity Laserguard Fibers (2010), 0 descendants of its own

## Indications for use
The Wave Form Manufacturing Prolase General Shaped Fiber is intended to be used in vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, bronchoscopes, cystoscopes, ureteroscopes, gastroscopes and colonoscopes, or for contact or non-contact surgery with or without handpiece for use in coagulation, incision/ excision, ablation and vaporization of soft tissue. The Wave Form Manufacturing Prolase General Shaped Fiber is indicated for use in medicine and surgery in the following medical specialties: Urology; Lithotripsy; Plastic Surgery; General and Vascular Surgery; Radiology; Arthroscopy; Dermatology; Podiatry; Pulmonolgy; Orthopedics; Gastroenterology; Neurosurgery; Gynecology; Plastic Surgery; ENT

Source page: https://510kreport.com/device/K020673
Methodology: https://510kreport.com/methodology