FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI— 510(k) K103132

Substantially Equivalent

Oculus Private Limited

FDA 510(k) clearance K103132 for FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI, Substantially Equivalent on 2011-09-08. Applicant: Oculus Private Limited.

Clearance details

Applicant: Oculus Private Limited
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2010-10-25
Decision date: 2011-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

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Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

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.