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Laser Laparoscopic Cholecystectomy

by Surgical Laser Technologies, Inc.

510(k) K901541

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK901541 Date13 Apr 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Laser Laparoscopic Cholecystectomy is a surgical laser system designed for use during laparoscopic removal of the gallbladder. It provides laser energy to cut, coagulate, or ablate tissue as part of the cholecystectomy procedure.

The device is marketed by Surgical Laser Technologies, Inc. and has received FDA 510(k) clearance (K901541) under product code GEX. It is supplied as a single unit for use in the operating room, with no specific sterility or reuse information provided in the data.

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