Cleared Abbreviated

K061120 - SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES

K061120 is an FDA 510(k) clearance for SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON..., manufactured by Synergeyes, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Abbreviated 510(k) pathway after a 62-day FDA review.

K061120 · Synergeyes, Inc. · Ophthalmic device
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Jun 2006
Decision
62d
Days
Class 2
Risk

K061120 is an FDA 510(k) clearance for the SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Synergeyes, Inc. (Rockville, US). The FDA issued a Cleared decision on June 22, 2006 after a review of 62 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Synergeyes, Inc. devices

FDA 510(k) Submission Details - K061120

510(k) Number K061120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2006
Decision Date June 22, 2006
Days to Decision 62 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 110d · This submission: 62d
Pathway characteristics
Standards-based clearance path.

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 83
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K061120.
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
K071043 · Bausch & Lomb, Inc. · Aug 2007
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
K070628 · Contamac, Ltd. · May 2007
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K062548 · Contamac, Ltd. · Nov 2006
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
K053124 · Bausch & Lomb, Incorporated · Jan 2006
SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS
K051035 · Synergeyes · Sep 2005
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K033594 · Contamac, Ltd. · Mar 2004