Cleared Traditional

Hyper GP (tisilfocon A) Daily Wear Contact Lens (K182304) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182304 · Contamac, Ltd. · Ophthalmic device
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Nov 2018
Decision
91d
Days
Class 2
Risk

K182304 is an FDA 510(k) clearance for the Hyper GP (tisilfocon A) Daily Wear Contact Lens. 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 November 23, 2018 after a review of 91 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

Submission Details

510(k) Number K182304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2018
Decision Date November 23, 2018
Days to Decision 91 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
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 22
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K182304.
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K201194 · Acuity Polymers, Inc. · Sep 2020
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens
K183167 · Bausch & Lomb, Incorporated · Feb 2019
BostonSight Scleral
K183175 · Bostonsight · Jan 2019
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K
K181579 · E&E Optics, Inc. · Jul 2018
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
K180988 · Acuity Polymers, Inc. · Jun 2018
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
K180616 · Contamac, Ltd. · Apr 2018