OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
FDA 510(k) clearance K053475 · decided 2006-03-03
Clearance details
- K-number
- K053475
- Device name
- OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
- Applicant
- Refractec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-14
- Decision date
- 2006-03-03
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- HMR
- Device class
- 1
- Regulation number
- 886.4570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (K925606) | Chiron Vision Corp. | 1994-08-29 |
| LASER CENTERING DEVICE (K872747) | Innomed Corp. | 1987-09-04 |
| OPHTHALMIC SURGICAL OCULAR MARKERS (K863663) | Myocure, Inc. | 1986-10-20 |
| OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU (K861535) | CooperVision, Inc. | 1986-05-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VIEWPOINT CK SYSTEM (P010018/S009) | Refractec, Inc. | 2006-04-06 |
| VIEWPOINT CK SYSTEM (P010018/S008) | Refractec, Inc. | 2005-09-30 |
| VIEWPOINT CONDUCTIVE KERATOPLASTY SYSTEM (P010018/S007) | Refractec, Inc. | 2005-03-22 |
| VIEWPOINT CK SYSTEM (P010018/S005) | Refractec, Inc. | 2004-03-16 |
| VIEWPOINT CK SYSTEM (P010018/S006) | Refractec, Inc. | 2004-01-15 |
| VIEWPOINT CK SYSTEM (P010018/S003) | Refractec, Inc. | 2003-11-06 |
| VIEWPOINT CK SYSTEM (P010018/S004) | Refractec, Inc. | 2003-07-31 |
| VIEWPOINT CK SYSTEM (P010018/S002) | Refractec, Inc. | 2003-06-09 |