AUTOMATIC TANGENT SCREEN 50
FDA 510(k) clearance K832800 · decided 1983-09-29
Clearance details
- K-number
- K832800
- Device name
- AUTOMATIC TANGENT SCREEN 50
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-18
- Decision date
- 1983-09-29
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- HOO
- Device class
- 1
- Regulation number
- 886.1605
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Southampton, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch CooperVision
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WELCH ALLYN GLAUCOMA DETECTOR (K941723) | Welch Allyn, Inc. | 1994-06-06 |
| MARCO PROJECTION PERIMETER (K930448) | Marco Ophthalmic, Inc. | 1993-06-21 |
| RICHMOND VISUAL FIELD SCREENER (K873912) | Richmond Products, Inc. | 1987-11-02 |
| HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN (K864467) | Keeler Instruments, Inc. | 1986-12-15 |
| DIGILAB CAMBRIDGE PERIMETER (K860115) | Bio-Rad | 1986-02-27 |
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 |