CEEON INTRAOCULAR LENSES
FDA premarket approval P960028/S016 · decided 2006-10-18
Approval details
- PMA number
- P960028
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CEEON INTRAOCULAR LENSES
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2006-10-10
- Decision date
- 2006-10-18
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE TO CLEAN ROOM SPECIFICATIONS TO IMPROVE EFFICIENCY, ENVIRONMENTAL SPECIFICATIONS AND MODIFICATIONS, AND CONTINUOUS PRODUCT FLOW.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
| VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (K203060) | Johnson & Johnson Surgical Vision, Inc. | 2021-03-12 |
| UNFOLDER Vitan Inserter (K191949) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (K191933) | Johnson & Johnson Surgical Vision, Inc. | 2019-08-16 |