LASER CENTERING DEVICE
FDA 510(k) clearance K872747 · decided 1987-09-04
Clearance details
- K-number
- K872747
- Device name
- LASER CENTERING DEVICE
- Applicant
- Innomed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-13
- Decision date
- 1987-09-04
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- HMR
- Device class
- 1
- Regulation number
- 886.4570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Brea, 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 |
|---|---|---|
| OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 (K053475) | Refractec, Inc. | 2006-03-03 |
| OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (K925606) | Chiron Vision Corp. | 1994-08-29 |
| 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.