K051922 is an FDA 510(k) clearance for the ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Cynosure, Inc. (Chelmsford, US). The FDA issued a Cleared decision on September 14, 2005, 61 days after receiving the submission on July 15, 2005.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K051922 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2005 |
| Decision Date | September 14, 2005 |
| Days to Decision | 61 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 |