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K242855

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

510(k) number
K242855
Device name
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
Applicant
E.O.S Co., Ltd. KR
Product code
LPL — Lenses, Soft Contact, Daily Wear
Decision date
2025-07-30
Date received
2024-09-20
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K242855.pdf

Official FDA record: K242855
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.