MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME— 510(k) K032978
Substantially EquivalentCiba Vision Corporation
FDA 510(k) clearance K032978 for MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME, Substantially Equivalent on 2003-10-20. Applicant: Ciba Vision Corporation. Device class: 1.
Clearance details
- Applicant
- Ciba Vision Corporation
- Product code
- Code HNO
- Device class
- Class 1
- Regulation
- 21 CFR 886.4370
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Duluth, GA, US
Recent devices under product code HNO
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- K123994 — DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
- K113168 — DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
- K083216 — CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
- K073459 — CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
Adverse events under product code HNO
product code HNO- Injury
- 390
- Total
- 390
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.