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Nuvolase 532 Cutaneous Laser System

by American Laser Medical

510(k) K990780

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 · Special NumberK990780 Date22 Mar 1999ClearedStatusActive

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  • Withdrawn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, 19 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 Nuvolase 532 Cutaneous Laser System is a continuous-wave, frequency-doubled diode-pumped Nd:YAG laser designed for cutaneous applications. It emits a 532 nm wavelength beam with adjustable power output ranging from 50 milliwatts to 1.5 watts, targeting vascular lesions of the skin, including capillary hemangiomas, telangiectasia, and rosacea.

This device is intended for use in clinical settings by trained professionals and is supplied as a reusable medical laser system. It has received FDA clearance under the 510(k) pathway (K990780) as a Class II device under product code GEX, classified under General and Plastic Surgery. No sterility or single-use specifications are noted in the regulatory data.

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