Cleared Traditional

K183670 - Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens

Also marketed or referenced as:
OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens

K183670 is an FDA 510(k) clearance for Vexillum Zephyr (olifilcon A) with Tang..., manufactured by Visco Vision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K183670 · Visco Vision, Inc. · Ophthalmic device
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Sep 2019
Decision
260d
Days
Class 2
Risk

K183670 is an FDA 510(k) clearance for the Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifoc.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Visco Vision, Inc. (Taoyuan City, TW). The FDA issued a Cleared decision on September 13, 2019 after a review of 260 days - an extended review 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: 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 Visco Vision, Inc. devices

FDA 510(k) Submission Details - K183670

510(k) Number K183670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2018
Decision Date September 13, 2019
Days to Decision 260 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
150d slower than avg
Panel avg: 110d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

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 Peers - LPL Lenses, Soft Contact, Daily Wear

All 349
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K183670.
OxySoft (olifilcon C) silicone hydrogel soft contact lens
K191397 · Visco Vision, Inc. · Oct 2019
ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens
K192129 · Clearlab SG Pte, Ltd. · Sep 2019
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
K191929 · Unicon Optical Co., Ltd. · Sep 2019
Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens
K191121 · Lentechs, LLC · Sep 2019
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
K182734 · Unicon Optical Co., Ltd. · May 2019
MyDay
K190965 · CooperVision, Inc. · Apr 2019