CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
FDA 510(k) clearance K082944 · decided 2008-10-16
Clearance details
- K-number
- K082944
- Device name
- CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-02
- Decision date
- 2008-10-16
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- MSS
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rochester, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
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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 |
|---|---|---|
| Bausch & Lomb SofLens® (polymacon) Contact Lenses (N16895/S107) | Bausch & Lomb, Inc. | 2025-10-24 |
| Akreos Posterior Chamber Intraocular Lens (P060022/S037) | Bausch & Lomb, Inc. | 2025-09-30 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S003) | Bausch & Lomb, Inc. | 2025-07-30 |
| Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S036) | Bausch & Lomb, Inc. | 2025-07-22 |
| Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S035) | Bausch & Lomb, Inc. | 2025-07-09 |
| enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S060) | Bausch & Lomb, Inc. | 2025-06-18 |
| enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S059) | Bausch & Lomb, Inc. | 2025-05-30 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S004) | Bausch & Lomb, Inc. | 2025-05-30 |