Cleared Traditional

AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens (K210609) - FDA 510(k) Clearance

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

K210609 · Vp Optics · Ophthalmic device
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Apr 2021
Decision
57d
Days
Class 2
Risk

K210609 is an FDA 510(k) clearance for the AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Vp Optics (Daejeon, KR). The FDA issued a Cleared decision on April 27, 2021 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vp Optics devices

Submission Details

510(k) Number K210609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2021
Decision Date April 27, 2021
Days to Decision 57 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
53d faster than avg
Panel avg: 110d · This submission: 57d
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

Eyereg Consulting, Inc.
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 99
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K210609.
ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
K210930 · Johnson & Johnson Vision Care, Inc. · Nov 2021
Avaira Vitality
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Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K210975 · Bausch & Lomb, Incorporated · May 2021
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere
K210436 · Alcon Laboratories, Inc. · Apr 2021
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo
K202129 · Largan Medical Co., Ltd. · Apr 2021
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
K200618 · Visco Vision, Inc. · Dec 2020