Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear— 510(k) K153766

Substantially Equivalent

INTEROJO, Inc.

FDA 510(k) clearance K153766 for Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, Substantially Equivalent on 2016-04-08. Applicant: INTEROJO, Inc..

Clearance details

Applicant: INTEROJO, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2015-12-30
Decision date: 2016-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyongtaek-City, KR

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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.