K152280 is an FDA 510(k) clearance for the BioPhotas Celluma3. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Biophotas, Inc. (Tustin, US). The FDA issued a Cleared decision on March 2, 2016, 203 days after receiving the submission on August 12, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K152280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2015 |
| Decision Date | March 02, 2016 |
| Days to Decision | 203 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 |