DeviceClearance

VISCO SOFT CONTACT LENS— 510(k) K141348

Substantially Equivalent

Visco Vision, Inc.

FDA 510(k) clearance K141348 for VISCO SOFT CONTACT LENS, Substantially Equivalent on 2015-06-22. Applicant: Visco Vision, Inc.. Device class: 2.

Clearance details

Applicant
Visco Vision, Inc.
Product code
Product 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
New Taipei, Luzhou Dist, TW
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 →

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