DeviceClearance

SUS (STENFILCON A) CONTACT LENS— 510(k) K131378

Substantially Equivalent

CooperVision, Inc.

FDA 510(k) clearance K131378 for SUS (STENFILCON A) CONTACT LENS, Substantially Equivalent on 2013-08-30. 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
Traditional
Location
Pleasanton, CA, US
Download summary PDFView on FDA.gov ↗

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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 K131378

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 K131378.

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