K123971 is an FDA 510(k) clearance for the CYNOSURE 1064NM DIODE LASER. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Cynosure, Inc. (Wesford, US). The FDA issued a Cleared decision on May 2, 2013, 127 days after receiving the submission on December 26, 2012.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K123971 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2012 |
| Decision Date | May 02, 2013 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILY - Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |