Cleared Traditional

K160977 - PolyDev Soft Contact Lenses

K160977 is an FDA 510(k) clearance for PolyDev Soft Contact Lenses, 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 97-day FDA review.

K160977 · Polydev , Ltd. · Ophthalmic device
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Jul 2016
Decision
97d
Days
Class 2
Risk

K160977 is an FDA 510(k) clearance for the PolyDev 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 July 13, 2016 after a review of 97 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 - K160977

510(k) Number K160977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2016
Decision Date July 13, 2016
Days to Decision 97 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
13d faster than avg
Panel avg: 110d · This submission: 97d
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 K160977.
ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)
K161098 · Joowon Innovation Co., Ltd. · Aug 2016
Hidrocor, Hidrocharme, and Natural Colors
K160472 · Solotica · Aug 2016
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · CooperVision, Inc. · Jul 2016
Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016
K160344 · Visco Vision, Inc. · May 2016
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
K152657 · Smart Performer Corp. , Ltd. · May 2016
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
K160609 · Alcon Laboratories, Inc. · May 2016