Cleared Traditional

K152724 - EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES

K152724 is an FDA 510(k) clearance for EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP L..., manufactured by Advanced Vision Technologies. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K152724 · Advanced Vision Technologies · Ophthalmic device
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Apr 2016
Decision
218d
Days
Class 2
Risk

K152724 is an FDA 510(k) clearance for the EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Advanced Vision Technologies (Lakewood, US). The FDA issued a Cleared decision on April 27, 2016 after a review of 218 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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 Advanced Vision Technologies devices

FDA 510(k) Submission Details - K152724

510(k) Number K152724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2015
Decision Date April 27, 2016
Days to Decision 218 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
108d slower than avg
Panel avg: 110d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
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

Eyereg Consulting, Inc.
BRET ANDRE

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 - HQD Lens, Contact (other Material) - Daily

All 82
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K152724.
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