SMARTKNIFE SYSTEM— 510(k) K853063
Substantially Equivalent for Some IndicationsCooperVision, Inc.
FDA 510(k) clearance K853063 for SMARTKNIFE SYSTEM, Substantially Equivalent for Some Indications on 1985-11-04. Applicant: CooperVision, Inc.. Device class: 1.
Clearance details
- Applicant
- CooperVision, Inc.
- Product code
- Code HNN
- Device class
- Class 1
- Regulation
- 21 CFR 886.4350
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code HNN
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- K213164 — Avaira Vitality
- K202756 — Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
- K191763 — MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
Adverse events under product code HNN
product code HNN- Injury
- 183
- Malfunction
- 4,106
- Total
- 4,289
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.