Cleared Traditional

K060102 - SYNERGEYES PS HYBRID CONTACT LENS

K060102 is an FDA 510(k) clearance for SYNERGEYES PS HYBRID CONTACT LENS, manufactured by Synergeyes, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K060102 · Synergeyes, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
61d
Days
Class 2
Risk

K060102 is an FDA 510(k) clearance for the SYNERGEYES PS HYBRID CONTACT LENS. 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 March 15, 2006 after a review of 61 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, Inc. devices

FDA 510(k) Submission Details - K060102

510(k) Number K060102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2006
Decision Date March 15, 2006
Days to Decision 61 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
49d faster than avg
Panel avg: 110d · This submission: 61d
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 83
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K060102.
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