The following data is part of a premarket notification filed by Luneau Ophtalmologie Sa with the FDA for Keratoref L60.
| Device ID | K922253 |
| 510k Number | K922253 |
| Device Name: | KERATOREF L60 |
| Classification | Keratoscope, Ac-powered |
| Applicant | LUNEAU OPHTALMOLOGIE SA B.P. 252 Chartres, Cedex, FR 28005 |
| Contact | Jean-noel Young |
| Correspondent | Jean-noel Young LUNEAU OPHTALMOLOGIE SA B.P. 252 Chartres, Cedex, FR 28005 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-01 |
| Decision Date | 1992-06-19 |