SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES— 510(k) K071203

Name: FDA 510(k) clearance K071203
Creator: U.S. Food and Drug Administration
Published: 2007-06-13

Substantially Equivalent

Optikem International, Inc.

FDA 510(k) clearance K071203 for SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES, Substantially Equivalent on 2007-06-13. Applicant: Optikem International, Inc.. Device class: 2.

Clearance details

Applicant: Optikem International, Inc.
Product code: Code LPN
Device class: Class 2
Regulation: 21 CFR 886.5928
Advisory panel: Ophthalmic
Date received: 2007-05-01
Decision date: 2007-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LPN

product code LPN

Injury: 333
Other: 8
Total: 341

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.