# K081424: Affirm CO2 and Affirm CO2 HP

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Mar 19, 2009 after 303 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smart CO2 laser: named in the summary without a submission number
- (no number) SmartXide CO2 with DOT Scanner laser: named in the summary without a submission number

## Most influential descendants
- K133895: Deka Smartxide Laser System (2014), 10 descendants of its own
- K100590: Edge CO2 Laser System (2010), 10 descendants of its own
- K162169: EdgeOne CO2 Laser (2016), 7 descendants of its own
- K201109: CO2 Laser Therapy System (2020), 5 descendants of its own
- K221597: CO2 Laser System (2022), 2 descendants of its own

## Indications for use
The Affirm CO 2 and Affirm CO 2 HP lasers with SmartScan scanner are indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental, and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Source page: https://510kreport.com/device/K081424
Methodology: https://510kreport.com/methodology