OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
FDA 510(k) clearance K861535 · decided 1986-05-14
Clearance details
- K-number
- K861535
- Device name
- OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-24
- Decision date
- 1986-05-14
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- HMR
- Device class
- 1
- Regulation number
- 886.4570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Bellevue, WA, 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 |
| LASER CENTERING DEVICE (K872747) | Innomed Corp. | 1987-09-04 |
| OPHTHALMIC SURGICAL OCULAR MARKERS (K863663) | Myocure, Inc. | 1986-10-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S033) | CooperVision, Inc. | 2025-12-23 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S032) | CooperVision, Inc. | 2025-12-17 |
| Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S193) | CooperVision, Inc. | 2025-12-11 |
| Sofmed® breathables XW NEXT (P080011/S191) | CooperVision, Inc. | 2025-12-05 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S031) | CooperVision, Inc. | 2025-10-28 |
| Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S192) | CooperVision, Inc. | 2025-09-22 |
| up&up Monthly Performance + (P080011/S184) | CooperVision, Inc. | 2025-08-20 |
| iWear oxygen presbyopia (P080011/S186) | CooperVision, Inc. | 2025-08-20 |