PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES— 510(k) K253885

Substantially Equivalent

GEO MEDICAL CO., LTD.

FDA 510(k) clearance K253885 for PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES, Substantially Equivalent on 2026-04-29. Applicant: GEO MEDICAL CO., LTD..

Clearance details

Applicant: GEO MEDICAL CO., LTD.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2025-12-04
Decision date: 2026-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buk-Gu, KR

Download summary PDF View on FDA.gov ↗

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.