Cleared Traditional

K152046 - Intelliwave4 with HPT

K152046 is an FDA 510(k) clearance for Intelliwave4 with HPT, manufactured by Art Optical Contact Lens, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K152046 · Art Optical Contact Lens, Inc. · Ophthalmic device
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Nov 2015
Decision
124d
Days
Class 2
Risk

K152046 is an FDA 510(k) clearance for the Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrof.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Art Optical Contact Lens, Inc. (Walker, US). The FDA issued a Cleared decision on November 24, 2015 after a review of 124 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 Art Optical Contact Lens, Inc. devices

FDA 510(k) Submission Details - K152046

510(k) Number K152046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2015
Decision Date November 24, 2015
Days to Decision 124 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 110d · This submission: 124d
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 165
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