CIBA VISION(R) CONTACT LENS CASE
FDA 510(k) clearance K943183 · decided 1994-08-04
Clearance details
- K-number
- K943183
- Device name
- CIBA VISION(R) CONTACT LENS CASE
- Applicant
- Ciba Vision Corporation
- Decision
- Substantially Equivalent
- Date received
- 1994-07-01
- Decision date
- 1994-08-04
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- LRX
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Duluth, GA, 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 |
|---|---|---|
| HYDROCURVE 3 TORIC (BUFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS (N17752/S038) | Ciba Vision Corporation | 2001-08-16 |
| SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A) (N17752/S037) | Ciba Vision Corporation | 2000-09-18 |
| CSI(CROFILCON A)EXTENDED WEAR SOFT (N17987/S028) | Ciba Vision Corporation | 2000-09-18 |
| CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A) (P850057/S006) | Ciba Vision Corporation | 2000-09-18 |
| GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES (P890012/S004) | Ciba Vision Corporation | 2000-09-12 |
| GENTLETOUCH (NETRAFILCON A)EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS (P890012/S005) | Ciba Vision Corporation | 2000-05-02 |
| CSI (CROFILCON A) EXTENDED WEAR SOFT (N17987/S027) | Ciba Vision Corporation | 1999-11-18 |
| CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS (N17987/S026) | Ciba Vision Corporation | 1999-08-30 |