UNFOLDER Vitan Inserter
FDA 510(k) clearance K191949 · decided 2019-09-13
Clearance details
- K-number
- K191949
- Device name
- UNFOLDER Vitan Inserter
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-22
- Decision date
- 2019-09-13
- Days to decision
- 53 days
- Clearance type
- Abbreviated
- Product code
- MSS
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Santa Ana, 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 |
|---|---|---|
| RxSight® Insertion Device (K261174) | Rxsight, Inc. | 2026-06-10 |
| ACCUJECT Injector Set 2.1-1P (LP604590) (K252540) | Medicel AG | 2025-09-16 |
| EyeGility™ Inserter for Preloaded enVista IOLs (K242389) | Bausch & Lomb, Incorporated | 2024-10-10 |
| Accuject Refra Injector AR2900 (K231106) | Medicel AG | 2023-09-19 |
| 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 |
| BL-Cart IOL Delivery Cartridge (K182965) | Ast Products, Inc. | 2019-03-29 |
| RxSight Insertion Device (K181401) | Rxsight, Inc. | 2018-07-26 |
Recalls involving this device
No recalls on record reference this clearance.