The following data is part of a premarket notification filed by Refractec, Inc. with the FDA for Optipoint Corneal Marker, Model Vpt-opt-450.
| Device ID | K053475 |
| 510k Number | K053475 |
| Device Name: | OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 |
| Classification | Marker, Ocular |
| Applicant | REFRACTEC, INC. 5 JENNER, SUITE 150 Irvine, CA 92618 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik REFRACTEC, INC. 5 JENNER, SUITE 150 Irvine, CA 92618 |
| Product Code | HMR |
| CFR Regulation Number | 886.4570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-14 |
| Decision Date | 2006-03-03 |