Cleared Traditional

K253885 - PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS (FDA 510(k) Clearance)

Also includes:
PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253885 · GEO MEDICAL CO., LTD. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
146d
Days
Class 2
Risk

K253885 is an FDA 510(k) clearance for the PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by GEO MEDICAL CO., LTD. (Buk-Gu, KR). The FDA issued a Cleared decision on April 29, 2026 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all GEO MEDICAL CO., LTD. devices

Submission Details

510(k) Number K253885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2025
Decision Date April 29, 2026
Days to Decision 146 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 110d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Andre Vision and Device Research
Bret Andre

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 482
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K253885.
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K254269 · St. shine Optical Co., Ltd. · Mar 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K252385 · Pegavision Corporation · Mar 2026
DAILIES TOTAL1®
K254052 · Alcon Laboratories, Inc. · Feb 2026
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)
K251683 · Bruno Vision Care, LLC · Dec 2025
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K250364 · St. shine Optical Co., Ltd. · Oct 2025
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear)
K244009 · Yung Sheng Optical Co., Ltd. · Sep 2025