K202028 is an FDA 510(k) clearance for the dermalux Flex MD. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Aesthetic Technology, Ltd. (Warrington, GB). The FDA issued a Cleared decision on December 16, 2020, 147 days after receiving the submission on July 22, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K202028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2020 |
| Decision Date | December 16, 2020 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ILY - Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |