Cleared Traditional

K172314 - Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

K172314 is an FDA 510(k) clearance for Ampleye Scleral RGP Lens (roflufocon D, manufactured by Art Optical Contact Lens, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K172314 · Art Optical Contact Lens, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
50d
Days
Class 2
Risk

K172314 is an FDA 510(k) clearance for the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D). Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Art Optical Contact Lens, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 2017 after a review of 50 days - a notably fast clearance 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: 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 Art Optical Contact Lens, Inc. devices

FDA 510(k) Submission Details - K172314

510(k) Number K172314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2017
Decision Date September 20, 2017
Days to Decision 50 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
60d faster than avg
Panel avg: 110d · This submission: 50d
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 108
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K172314.
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
K180616 · Contamac, Ltd. · Apr 2018
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG
K180172 · Paragon Vision Sciences · Mar 2018
ENFLU 18 (enflufocon A) Daily Wear Contact Lens
K171575 · Contamac, Ltd. · Oct 2017
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
K171950 · Visionary Optics, LLC · Aug 2017
HEXA100 (hexafocon A) Daily Wear Contact Lenses
K171077 · Contamac, Ltd. · Aug 2017
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
K171404 · Bausch & Lomb, Incorporated · Jul 2017