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Vydence Laser Family

by Vydence Medical Industria e Comercio Ltda 510(k)

Active United States

510(k) K190007

Overview

The Vydence Laser Family is a class of fractional laser devices designed for non-ablative skin resurfacing and collagen stimulation. These lasers target deep tissue to treat conditions such as wrinkles, stretch marks, acne scars, and active acne by delivering controlled energy to promote tissue remodeling and rejuvenation.

The devices are intended for use in clinical settings by trained professionals, supplied as reusable medical equipment under FDA 510(k) clearance (K190007). They are regulated under the General, Plastic Surgery advisory committee category and are not classified as single-use. No specific sterility or MRI safety details are provided in the submitted data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190007 Date1 Mar 2019ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from Vydence Medical Industria e Comercio Ltda

Questions

  • What types of skin conditions can the Vydence Laser Family treat, and how does it work to address them?

    The Vydence Laser Family is designed for non-ablative skin resurfacing and collagen stimulation, targeting deep tissue to treat wrinkles, stretch marks, acne scars, and active acne. It achieves this by delivering controlled laser energy to promote tissue remodeling and rejuvenation, encouraging natural collagen production without removing the outer skin layer.

  • Is the Vydence Laser Family intended for single-use or reusable in clinical settings?

    The Vydence Laser Family is supplied as reusable medical equipment, meaning it is not designed for single-use. It is intended for use in clinical settings by trained professionals, where proper cleaning and maintenance protocols should be followed to ensure safety and efficacy.

  • How is the Vydence Laser Family regulated, and what does its FDA clearance status mean for buyers?

    The Vydence Laser Family holds FDA clearance under the 510(k) pathway (K190007) and is classified under the General, Plastic Surgery advisory committee category. This means it has been determined to be substantially equivalent to a legally marketed device and meets FDA requirements for safety and effectiveness in its intended clinical use.

  • Are there specific storage requirements for the Vydence Laser Family, and does it come with any sterility guarantees?

    The provided data does not specify any particular sterility guarantees or detailed storage requirements for the Vydence Laser Family. Since it is reusable, proper handling, cleaning, and maintenance procedures must be followed to ensure safe and effective use in clinical environments.