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Laserpro CO2 Carbon Dioxide Laser System

by Photo Medex, Inc.

510(k) K040234

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 NumberK040234 Date2 Apr 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  • Withdrawn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 Laserpro Co2 Carbon Dioxide Laser System is a surgical laser device indicated for use in procedures requiring the ablation, vaporization, excision, and coagulation of soft tissue. It is used in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, and otolaryngology.

The system is supplied with delivery accessories identified in the user instructions for delivering laser energy. It includes laser safety signs and laser safety glasses for physician, patient, and nurse. The device is designed for use with a foot switch (standard) or finger touch (available with certain fibers) for laser control, and features an easy-to-operate user interface, small footprint, lightweight and transportable design, with an optional cart available.

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