Cleared Traditional

K161931 - Toricolors (hioxifilcon D) Soft Contact Lenses

K161931 is an FDA 510(k) clearance for Toricolors (hioxifilcon D) Soft Contact..., manufactured by Polydev , Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K161931 · Polydev , Ltd. · Ophthalmic device
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Oct 2016
Decision
90d
Days
Class 2
Risk

K161931 is an FDA 510(k) clearance for the Toricolors (hioxifilcon D) Soft Contact Lenses. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Polydev , Ltd. (Collon, IE). The FDA issued a Cleared decision on October 12, 2016 after a review of 90 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 Polydev , Ltd. devices

FDA 510(k) Submission Details - K161931

510(k) Number K161931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2016
Decision Date October 12, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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 Consultant

Licensale, Inc.
RAY KELLY

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 350
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K161931.
Visco (olifilcon A) soft contact lens
K160245 · Visco Vision, Inc. · Oct 2016
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AIR OPTIX COLORS
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Hidrocor, Hidrocharme, and Natural Colors
K160472 · Solotica · Aug 2016