MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
FDA 510(k) clearance K032978 · decided 2003-10-20
Clearance details
- K-number
- K032978
- Device name
- MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
- Applicant
- Ciba Vision Corporation
- Decision
- Substantially Equivalent
- Date received
- 2003-09-24
- Decision date
- 2003-10-20
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- HNO
- Device class
- 1
- Regulation number
- 886.4370
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Duluth, GA, US
- Third-party review
- No
- Expedited review
- No
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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 |