K051537 is an FDA 510(k) clearance for the HILT FAMILY LASER: HILT I, HILT II, HILT III. 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 26, 2005, 108 days after receiving the submission on June 10, 2005.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K051537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2005 |
| Decision Date | September 26, 2005 |
| Days to Decision | 108 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 |