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510(k) K242855

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) by E.O.S Co., Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2025
Date Received
September 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

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