K122237 is an FDA 510(k) clearance for the BIOPHOTAS LIFELIGHT. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Biophotas, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on January 3, 2013, 161 days after receiving the submission on July 26, 2012.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K122237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2012 |
| Decision Date | January 03, 2013 |
| Days to Decision | 161 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 |