SERIES TEN THOUSAND COMPACT
FDA 510(k) clearance K861565 · decided 1986-07-11
Clearance details
- K-number
- K861565
- Device name
- SERIES TEN THOUSAND COMPACT
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-25
- Decision date
- 1986-07-11
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- HQE
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- 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 |
|---|---|---|
| UniVit HE, UniVit UHS (K212763) | Visioncare Devices, LLC | 2022-08-10 |
| Cetus system, Cetus probe (K170183) | A.R.C Laser GmbH | 2017-09-27 |
| Bi-Blade Vitrectomy Cutter (K153168) | Medical Instrument Development Laboratories | 2016-04-29 |
| CONSTELLATION VISION SYSTEM (K141065) | Alcon Research, Ltd. | 2014-08-22 |
| VERSAVIT (K121675) | Synergetics, Inc. | 2012-06-21 |
| PROCARE PLUS VITRECTOMY SYSTEM (K120170) | Visioncare Devices, Inc. | 2012-05-30 |
| ULTIMATE VIT ENHAMCER (UVE) (K102222) | Medical Instrument Development Laboratories, Inc. | 2011-04-08 |
| COLIBRI DISPOSABLE VITRECTOMY CUTTER (K033390) | Microworld Medical Instruments, Inc. | 2003-11-04 |
| VMATE MODEL VMM1000 (K030948) | Howard Instruments, Inc. | 2003-06-17 |
| VELOCITY ADVANTAGE (K023939) | Visioncare Devices, Inc. | 2003-04-17 |
| MID LABS AUTONOMOUS VIT ENHANCER (AVE) (K020911) | Medical Instrument Development Laboratories, Inc. | 2002-04-29 |
| D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (K010082) | Dutch Ophthalmic USA, Inc. | 2001-03-12 |
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 |