Cleared Traditional

K940277 - PAFLUFOCON A

K940277 is an FDA 510(k) clearance for PAFLUFOCON A, manufactured by Paragon Vision Sciences. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K940277 · Paragon Vision Sciences · Ophthalmic device
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May 1994
Decision
110d
Days
Class 2
Risk

K940277 is an FDA 510(k) clearance for the PAFLUFOCON A, B, C & D. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Paragon Vision Sciences (Phoenix, US). The FDA issued a Cleared decision on May 9, 1994 after a review of 110 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 Paragon Vision Sciences devices

FDA 510(k) Submission Details - K940277

510(k) Number K940277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1994
Decision Date May 09, 1994
Days to Decision 110 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 110d · This submission: 110d
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.