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Fotona Skinlight Plus Nd: Yag System

by Medical Laser Solutions

510(k) K972368

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 NumberK972368 Date23 Sep 1997ClearedStatusActive

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  • Withdrawn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 Fotona Skinlight Plus Nd: Yag System is a laser system that utilizes a Nd: Yag crystal activated by flashlamps within an optical cavity. It is a Class 2 General and Plastic Surgery device. The system combines two complementary laser wavelengths, Er: Yag and Nd: Yag, in a single treatment. This combination makes use of the unique laser-tissue interaction characteristics of each laser wavelength.

The Fotona Skinlight Plus Nd: Yag System is supplied as an accessory sub-system to a previously cleared Er: Yag laser. It is cleared through the Traditional 510(k) pathway with the product code GEX. The device has FDA 510(k) clearance, indicated by the authorization number K972368. The system is used in aesthetic applications, with a red diode aiming beam.

Other devices from Medical Laser Solutions

Questions

AI-generated answers, 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.

  • What is the Fotona Skinlight Plus Nd: Yag System used for?

    The system is used in aesthetic applications, utilizing a combination of Er: Yag and Nd: Yag laser wavelengths for unique laser-tissue interaction characteristics.

  • How is the Fotona Skinlight Plus Nd: Yag System supplied?

    The system is supplied as an accessory sub-system to a previously cleared Er: Yag laser.

  • What is the regulatory status of the Fotona Skinlight Plus Nd: Yag System?

    The system has FDA 510(k) clearance, indicated by the authorization number K972368, and was cleared through the Traditional 510(k) pathway with the product code GEX.