The following data is part of a premarket notification filed by Dominion Aesthetic Technologies, Inc. with the FDA for Eon.
| Device ID | K211681 |
| 510k Number | K211681 |
| Device Name: | EON |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Dominion Aesthetic Technologies, Inc. 2431 Aloma Avenue Suite 225 Winter Park, FL 32792 |
| Contact | Ahmed Mohammed |
| Correspondent | Ahmed Mohammed Dominion Aesthetic Technologies, Inc. 2431 Aloma Avenue Suite 225 Winter Park, FL 32792 |
| Product Code | GEX |
| Subsequent Product Code | OOK |
| Subsequent Product Code | PKT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2022-03-30 |