K111901 is an FDA 510(k) clearance for the ASA 'MPHI FAMILY 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 November 9, 2011, 127 days after receiving the submission on July 5, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K111901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2011 |
| Decision Date | November 09, 2011 |
| Days to Decision | 127 days |
| Submission Type | Special |
| 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 |