Model 5050 Surgilaser for Urology Use

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K871932 ↗

FDA Product Code

LNK

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Model 5050 Surgilaser for Neurosurgery Use

  Class II

  FDA 510(k) K871933 Active Cleared 22 Jan 1988

• Model 5050 Surgilaser for Gastro-Intestinal Use

  Class II

  FDA 510(k) K871934 Active Cleared 25 Mar 1988

• Modified Combolaser 5050 & New Model 5050 Ver. 33

  Class II

  FDA 510(k) K901638 Active Cleared 27 Jun 1990

• Lasermatic Supercombo Surgical Laser System

  Class II

  FDA 510(k) K903131 Active Cleared 19 Feb 1991

• Model 5050 Surgilaser for Ob-Gyn Use

  Class II

  FDA 510(k) K871875 Active Cleared 22 Aug 1988

• Model 5050 Surgilaser for Pulmonary Use

  Class II

  FDA 510(k) K871876 Active Cleared 22 Jan 1988

See all devices from Lasermatic, Inc. →

• What is the MODEL 5050 SURGILASER used for?

  The MODEL 5050 SURGILASER is a surgical laser system designed for use in urological procedures, as defined in the regulatory nomenclature for Laser For Gastro-Urology Use, and is intended for clinical settings such as general and plastic surgery environments.

• How is the MODEL 5050 SURGILASER supplied and is it reusable?

  The device is supplied non-sterile and is designed for reusable use in clinical settings, meaning it must be cleaned and sterilized by the user before each procedure according to established reprocessing protocols.

• What regulatory pathway was used to clear the MODEL 5050 SURGILASER?

  The MODEL 5050 SURGILASER was cleared via the FDA 510(k) process under submission K871932 with a traditional clearance pathway, demonstrating substantial equivalence to a legally marketed predicate device.