The following data is part of a premarket notification filed by Aesthetic Technology Ltd. with the FDA for Dermalux Tri-wave Md.
| Device ID | K200659 |
| 510k Number | K200659 |
| Device Name: | Dermalux Tri-Wave MD |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Aesthetic Technology Ltd. 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-12 |
| Decision Date | 2020-05-09 |