The following data is part of a premarket notification filed by Aesthetic Technology Ltd with the FDA for Dermalux Flex Md.
| Device ID | K202028 |
| 510k Number | K202028 |
| Device Name: | Dermalux Flex MD |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | Aesthetic Technology Ltd Unit 211 Europa Blvd Warrington, GB Wa5 7tn |
| Contact | Dale Needham |
| Correspondent | Richard Hamer Richard Hamer Associates LLC 705 Spring Lakes Blvd Bradenton, FL 34210 |
| Product Code | ILY |
| Subsequent Product Code | GEX |
| Subsequent Product Code | OHS |
| Subsequent Product Code | OLP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-22 |
| Decision Date | 2020-12-16 |