Cleared Traditional

K171077 - HEXA100 (hexafocon A) Daily Wear Contact Lenses

K171077 is an FDA 510(k) clearance for HEXA100 (hexafocon A) Daily Wear Contac..., manufactured by Contamac, Ltd.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K171077 · Contamac, Ltd. · Ophthalmic device
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Aug 2017
Decision
112d
Days
Class 2
Risk

K171077 is an FDA 510(k) clearance for the HEXA100 (hexafocon A) Daily Wear Contact Lenses. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Contamac, Ltd. (Saffron Walden, GB). The FDA issued a Cleared decision on August 1, 2017 after a review of 112 days - within the typical 510(k) review window.

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 Contamac, Ltd. devices

FDA 510(k) Submission Details - K171077

510(k) Number K171077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2017
Decision Date August 01, 2017
Days to Decision 112 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
2d slower than avg
Panel avg: 110d · This submission: 112d
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 K171077.
ENFLU 18 (enflufocon A) Daily Wear Contact Lens
K171575 · Contamac, Ltd. · Oct 2017
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
K172314 · Art Optical Contact Lens, Inc. · Sep 2017
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
K171950 · Visionary Optics, LLC · Aug 2017
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
K171404 · Bausch & Lomb, Incorporated · Jul 2017
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
K170001 · Acuity Polymers, Inc. · Jun 2017
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
K170007 · Acuity Polymers, Inc. · May 2017