KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR— 510(k) K870265
Substantially EquivalentCooperVision, Inc.
FDA 510(k) clearance K870265 for KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR, Substantially Equivalent on 1987-02-20. Applicant: CooperVision, Inc.. Device class: 1.
Clearance details
- Applicant
- CooperVision, Inc.
- Product code
- Code KYB
- Device class
- Class 1
- Regulation
- 21 CFR 886.4300
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellevue, WA, US
Recent devices under product code KYB
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- K213164 — Avaira Vitality
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- K191763 — MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
Adverse events under product code KYB
product code KYB- Injury
- 218
- Malfunction
- 1,989
- Other
- 1
- Total
- 2,208
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.