K253885
- 510(k) number
- K253885
- Device name
- PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES
- Applicant
- GEO MEDICAL CO., LTD. KR
- Product code
- LPL — Lenses, Soft Contact, Daily Wear
- Decision date
- 2026-04-29
- Date received
- 2025-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253885.pdf
Official FDA record: K253885
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.