HOYA IS INJECTOR SYSTEM
FDA 510(k) clearance K081346 · decided 2009-03-23
Clearance details
- K-number
- K081346
- Device name
- HOYA IS INJECTOR SYSTEM
- Applicant
- Hoya Surgical Optics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-05-14
- Decision date
- 2009-03-23
- Days to decision
- 313 days
- Clearance type
- Traditional
- Product code
- MSS
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chino Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| RxSight® Insertion Device (K261174) | Rxsight, Inc. | 2026-06-10 |
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| RxSight® Insertion Device (63002) (K231838) | Rxsight, Inc. | 2023-08-15 |
| RxSight Insertion Device (K231466) | Rxsight, Inc. | 2023-06-12 |
| CLAREON MONARCH IV IOL Delivery System (K212039) | Alcon Laboratories, Inc. | 2021-08-23 |
| bioli lOL Delivery System (K200057) | Ast Products, Inc. | 2020-06-04 |
| RxSight Insertion Device (K192926) | Rxsight, Inc. | 2020-01-17 |
| Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005) | Bausch & Lomb, Inc. | 2019-10-04 |
| UNFOLDER Vitan Inserter (K191949) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| BL-Cart IOL Delivery Cartridge (K182965) | Ast Products, Inc. | 2019-03-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure Preloaded IOL System / Model B1PC (Clear (P080004/S047) | Hoya Surgical Optics, Inc. | 2023-10-25 |
| iSert Preloaded IOL System, IPure Preloaded IOL System (P080004/S045) | Hoya Surgical Optics, Inc. | 2023-06-22 |
| iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231 & IPure Preloaded IOL System/ Model B1PC (Clear (P080004/S046) | Hoya Surgical Optics, Inc. | 2023-05-04 |
| PreVue Pre-Loaded System (P080004/S042) | Hoya Surgical Optics, Inc. | 2022-02-28 |
| iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System (P080004/S043) | Hoya Surgical Optics, Inc. | 2021-12-28 |
| PreVue Pre-loaded System, IPURE Pre-loaded System (P080004/S041) | Hoya Surgical Optics, Inc. | 2021-06-10 |
| iSert Preloaded System (P080004/S031) | Hoya Surgical Optics, Inc. | 2021-05-21 |
| iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System (P080004/S040) | Hoya Surgical Optics, Inc. | 2021-05-07 |