The following data is part of a premarket notification filed by Luneau Technology Operations with the FDA for Vx650.
| Device ID | K202221 |
| 510k Number | K202221 |
| Device Name: | VX650 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Luneau Technology Operations 2 Rue Roger Bonnet Pont-de-l'arche, FR 27340 |
| Contact | Yossi Constantinis |
| Correspondent | Yossi Constantinis Luneau Technology Operations 2 Rue Roger Bonnet Pont-de-l'arche, FR 27340 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-06 |
| Decision Date | 2021-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03664188000145 | K202221 | 000 |