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Nannolight Intense Pulsed Light System

by Global USA Distribution, LLC

510(k) K082033

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK082033 Date31 Jul 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1444-2009 FDA Unclassified (pre-2012) initiated 12 Apr 2008

    Sybaritic Inc. had an issue with the 585nm filter used with the NannoLight MP50. The filter may cause unwanted burning and should not be used for vascular lesion treatments.

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  • Withdrawn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, 23 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 Nannolight Intense Pulsed Light System is a device used for general and plastic surgery applications. It delivers intense pulsed light energy for therapeutic or aesthetic procedures as indicated by its device type and clearance.

The system was cleared through the FDA 510(k) process under K082033 with product code GEX and is substantially equivalent to a predicate device. It is manufactured by Global USA Distribution, LLC and was granted traditional clearance on July 31, 2008.

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