Cleared Traditional

K202860 - Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) (FDA 510(k) Clearance)

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

K202860 · Valley Contax, Inc. · Ophthalmic device
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May 2021
Decision
225d
Days
Class 2
Risk

K202860 is an FDA 510(k) clearance for the Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, ro.... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Valley Contax, Inc. (Springfield, US). The FDA issued a Cleared decision on May 11, 2021 after a review of 225 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 Valley Contax, Inc. devices

Submission Details

510(k) Number K202860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date May 11, 2021
Days to Decision 225 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
115d slower than avg
Panel avg: 110d · This submission: 225d
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 117
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K202860.
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