Home / 510(k) Clearances / K253885

510(k) K253885

PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES by GEO MEDICAL CO., LTD. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2026
Date Received
December 4, 2025
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

Other clearances by GEO MEDICAL CO., LTD.

  • K110835 — GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (April 26, 2012)

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  • K250364 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contac (October 7, 2025)
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  • K242855 — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (July 30, 2025)
  • K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (July 2, 2025)