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Powerlite 600 Ex System

by Preswede AB

510(k) K033933

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 NumberK033933 Date16 Mar 2004ClearedStatusActive

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  • Withdrawn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 Powerlite 600 Ex System is a powered laser surgical instrument. It is classified under product code GEX and regulation number 21 CFR 878.4810 for use in general and plastic surgery procedures.

The device received FDA 510(k) clearance (K033933) on March 16, 2004, as substantially equivalent to a predicate device. It was reviewed by the General & Plastic Surgery advisory committee and is manufactured by Preswede AB.

Other devices from Preswede AB

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 Powerlite 600 Ex System used for?

    The Powerlite 600 Ex System is a powered laser surgical instrument intended for use in general and plastic surgery procedures, as indicated by its classification under product code GEX and regulation 21 CFR 878.4810.

  • How was the Powerlite 600 Ex System cleared for market?

    The device received FDA 510(k) clearance (K033933) on March 16, 2004, as substantially equivalent to a predicate device, following review by the General & Plastic Surgery advisory committee.

  • Who manufactures the Powerlite 600 Ex System?

    The Powerlite 600 Ex System is manufactured by Preswede AB, with the applicant listed as Preswede AB and contact person Susan D Goldstein-Falk based in Great Neck, NY.