K042165 is an FDA 510(k) clearance for the CUTERA TABLETOP AESTHETIC PRODUCT. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Cutera, Inc. (Brisbane, US). The FDA issued a Cleared decision on October 18, 2004, 68 days after receiving the submission on August 11, 2004.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K042165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2004 |
| Decision Date | October 18, 2004 |
| Days to Decision | 68 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 |