The following data is part of a premarket notification filed by Venus Concept Usa Inc. with the FDA for Venus Epileve.
| Device ID | K200786 |
| 510k Number | K200786 |
| Device Name: | Venus Epileve |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston, FL 33326 |
| Contact | Yoni Iger |
| Correspondent | Elissa Burg BioVision Ltd Had Nes 183 Had Nes, IL 1295000 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-26 |
| Decision Date | 2020-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016541984 | K200786 | 000 |