DeviceClearance

MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens— 510(k) K220070

Substantially Equivalent

CooperVision, Inc.

FDA 510(k) clearance K220070 for MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens, Substantially Equivalent on 2022-02-04. Applicant: CooperVision, Inc.. Device class: 2.

Clearance details

Applicant
CooperVision, Inc.
Product code
Code LPL
Device class
Class 2
Regulation
21 CFR 886.5925
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Ramon, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LPL

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More clearances from CooperVision, Inc.

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Adverse events under product code LPL

product code LPL
Injury
988
Other
4
Total
992

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 →

Recalls naming K220070

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220070.

Data sourced from openFDA. This site is unofficial and independent of the FDA.