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Model 130-SAC Aspirating Endophotocoagulator Laser

by Mnlase, Inc.

510(k) K944624

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 NumberK944624 Date1 Nov 1994ClearedStatusActive

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  • Withdrawn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, 22 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 Model 130-SAC Aspirating Endophotocoagulator Laser is a device used for photocoagulation procedures, combining laser energy delivery with aspiration functionality. It is designed for use in general and plastic surgery applications as indicated by its advisory committee classification.

This device received FDA 510(k) clearance under K944624 on November 1, 1994, and is substantially equivalent to a predicate device. It is manufactured by Mnlase, Inc. and identified by product code GEX. The device is supplied as a reusable system and is intended for use in clinical settings where laser-assisted tissue coagulation with simultaneous aspiration is required.

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