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Conbio Medlite Q-Switched Nd:Yag Laser System

by Continuum Biomedical, Inc. 3 variants

510(k) K940636

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 NumberK940636 Date31 May 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  • Withdrawn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, 6 Oct 2026

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

This is a powered laser surgical instrument classified under the GEX product code, which encompasses powered laser surgical instruments across multiple specialties. The device is a Q-switched Nd:YAG laser system designed for use in general and plastic surgery procedures.

It received FDA 510(k) clearance K940636 on May 31, 1994, following a traditional review process and was found substantially equivalent to a predicate device. The system is supplied as a reusable laser system for use in clinical settings, with no indication of sterility, single-use status, MRI safety, specific sizes, or storage requirements provided in the data.

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