Skip to content

Vydence Family of Lasers

by Vydence Medical Industria E Commercio Ltda

510(k) K252753

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 NumberK252753 Date24 Jan 2026ClearedStatusActive

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  • Withdrawn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.

The Vydence Family of Lasers is a laser surgical instrument designed for use in general and plastic surgery. It functions as a medical laser system intended for surgical applications within these clinical specialties.

This device has received FDA 510(k) clearance. It is manufactured by Vydence Medical Industria E Commercio Ltda and is identified by the reference number K252753.

Questions

AI-generated answers, 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.

  • What is the Vydence Family of Lasers used for?

    The Vydence Family of Lasers is a medical laser system specifically engineered for use in general and plastic surgery applications.

  • What is the regulatory status of the Vydence Family of Lasers?

    This device is identified by the reference number K252753 and has received FDA 510(k) clearance, confirming it is substantially equivalent to existing devices.

  • Who is the manufacturer of this laser surgical instrument?

    The Vydence Family of Lasers is manufactured by Vydence Medical Industria E Commercio Ltda, located in Sao Carlos, Brazil.