The following data is part of a premarket notification filed by Luneau Sas with the FDA for Vx130 Ophthalmic Diagnostic Device.
| Device ID | K162067 |
| 510k Number | K162067 |
| Device Name: | VX130 Ophthalmic Diagnostic Device |
| Classification | Tonometer, Ac-powered |
| Applicant | LUNEAU SAS 1 AVE DE MALAGUET Prunay-le-gillon, FR 28360 |
| Contact | Isabelle Durand |
| Correspondent | Isabelle Durand LUNEAU SAS 1 AVE DE MALAGUET Prunay-le-gillon, FR 28360 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-26 |
| Decision Date | 2017-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03664188000930 | K162067 | 000 |
| 03664188000923 | K162067 | 000 |