DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D— 510(k) K123431

Substantially Equivalent

Dreamcon Co., Ltd.

FDA 510(k) clearance K123431 for DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D, Substantially Equivalent on 2013-06-17. Applicant: Dreamcon Co., Ltd..

Clearance details

Applicant: Dreamcon Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2012-11-07
Decision date: 2013-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission Viejo, CA, 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.