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Affirm CO2 and Affirm CO2 HP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K081424

by Cynosure, Inc.

Identifiers

510(k) Number
K081424 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A powered laser surgical instrument classified under product code GEX, the Affirm CO2 and Affirm CO2 HP is a device used in general and plastic surgery procedures. It is designed for the treatment of skin conditions such as deep wrinkles, significant photoaging, and severe scar damage.

Supplied by Cynosure, Inc., the device received FDA 510(k) clearance under K081424 on March 19, 2009, following a traditional review process. It is classified as a Class II device with special controls and is intended for use in clinical settings by trained professionals.

Frequently asked questions

What is the Affirm CO2 and Affirm CO2 HP used for?

The Affirm CO2 and Affirm CO2 HP is a powered laser surgical instrument used in general and plastic surgery procedures to treat skin conditions such as deep wrinkles, significant photoaging, and severe scar damage. It is designed for clinical use by trained professionals to deliver precise laser energy for tissue ablation and remodeling.

How is the Affirm CO2 and Affirm CO2 HP supplied and cleared for use?

The device is supplied by Cynosure, Inc. and received FDA 510(k) clearance under K081424 on March 19, 2009, following a traditional review process. It is classified as a Class II device with special controls under product code GEX, indicating it is substantially equivalent to a legally marketed predicate device.

Is the Affirm CO2 and Affirm CO2 HP intended for single-use or reuse?

The device data does not specify whether the Affirm CO2 and Affirm CO2 HP is intended for single-use or reuse. As a powered laser surgical instrument, it likely includes reusable components such as the laser console and handpieces, with disposable accessories like tips or lenses, but this detail is not provided in the authorization or description fields.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K081424 - AFFIRM CO2 AND AFFIRM CO2 HP | FDA 510 (k), AFFIRM CO2 AND AFFIRM CO2 HP 510 (k) K081424 - FDA.report, Cynosure Affirm CO2 - UsedLaserPro

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cynosure, Inc.

Sources (1)

  • FDA 510(k) K081424 24 fields · synced Sep 26, 2026