Cleared Traditional

K200618 - HydroSens A (hioxifilcon A) Spherical H...

K200618 is the FDA 510(k) clearance for HydroSens A (hioxifilcon A) Spherical H... by Visco Vision, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K200618 · Visco Vision, Inc. · Ophthalmic device
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Dec 2020
Decision
273d
Days
Class 2
Risk

K200618 is an FDA 510(k) clearance for the HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens. 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 December 7, 2020 after a review of 273 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

Submission Details

510(k) Number K200618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2020
Decision Date December 07, 2020
Days to Decision 273 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
163d slower than avg
Panel avg: 110d · This submission: 273d
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 Peers - LPL Lenses, Soft Contact, Daily Wear

All 160
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