VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS
FDA 510(k) clearance K953804 · decided 1995-09-26
Clearance details
- K-number
- K953804
- Device name
- VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-08
- Decision date
- 1995-09-26
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Jacksonville, FL, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ACUVUE CONTACT LENS (N18033/S112) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2025-12-16 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S111) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2023-08-21 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S110) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2022-12-16 |
| VISTAKON® (etafilcon A) Brand Contact Lenses (N18033/S109) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2022-09-22 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S108) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2020-11-19 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S107) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2020-06-01 |
| Vistakon (etafilcon A) Brand Contact Lenses (N18033/S105) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2019-06-07 |
| VISTAKON (etafilcon A) Brand Contact Lenses. (N18033/S101) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2019-05-31 |