Cleared Traditional

K052675 - SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS

K052675 is an FDA 510(k) clearance for SYNERGEYES KC (PAFLUFOCON D HEM-IBERFIL..., manufactured by Synergeyes. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K052675 · Synergeyes · Ophthalmic device
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Nov 2005
Decision
64d
Days
Class 2
Risk

K052675 is an FDA 510(k) clearance for the SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOC.... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Synergeyes (Rockville, US). The FDA issued a Cleared decision on November 30, 2005 after a review of 64 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 Synergeyes devices

FDA 510(k) Submission Details - K052675

510(k) Number K052675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2005
Decision Date November 30, 2005
Days to Decision 64 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 110d · This submission: 64d
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 Peers - HQD Lens, Contact (other Material) - Daily

All 72
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