Cleared Traditional

K171157 - PolyDev Soft Contact Lenses

K171157 is the FDA 510(k) clearance for PolyDev Soft Contact Lenses by Polydev , Ltd.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K171157 · Polydev , Ltd. · Ophthalmic device
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Jun 2017
Decision
43d
Days
Class 2
Risk

K171157 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 June 2, 2017 after a review of 43 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 Polydev , Ltd. devices

Submission Details

510(k) Number K171157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2017
Decision Date June 02, 2017
Days to Decision 43 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 110d · This submission: 43d
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 161
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K171157.
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