The following data is part of a premarket notification filed by E-swin with the FDA for E>eyec.
| Device ID | K200616 |
| 510k Number | K200616 |
| Device Name: | E>EyeC |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | E-SWIN Rue Des Cotes D'orval, ZA De La Prevote Houdan, FR 78550 |
| Contact | Emeric Obin |
| Correspondent | Emeric Obin E-SWIN Rue Des Cotes D'orval, ZA De La Prevote Houdan, FR 78550 |
| Product Code | ONF |
| Subsequent Product Code | GEX |
| Subsequent Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-09 |
| Decision Date | 2020-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662824000207 | K200616 | 000 |