ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
FDA 510(k) clearance K994324 · decided 2000-02-23
Clearance details
- K-number
- K994324
- Device name
- ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-22
- Decision date
- 2000-02-23
- Days to decision
- 63 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 |
|---|---|---|
| VISTAKON® (etafilcon A) Brand Contact Lenses (N18033/S114) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2026-04-17 |
| VISTAKON® (etafilcon A) lenses (N18033/S113) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2026-03-10 |
| 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 |