Cleared Traditional

K142510 - UltraHealth Hybrid Contact Lens for Ker...

K142510 is the FDA 510(k) clearance for UltraHealth Hybrid Contact Lens for Ker... by Synergeyes, Inc.. It is a Class 2 Ophthalmic device (product code HQD) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K142510 · Synergeyes, Inc. · Ophthalmic device
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Nov 2014
Decision
72d
Days
Class 2
Risk

K142510 is an FDA 510(k) clearance for the UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybr.... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Synergeyes, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 19, 2014 after a review of 72 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

Submission Details

510(k) Number K142510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2014
Decision Date November 19, 2014
Days to Decision 72 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
38d faster than avg
Panel avg: 110d · This submission: 72d
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 Peers - HQD Lens, Contact (other Material) - Daily

All 26
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K142510.
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
K180988 · Acuity Polymers, Inc. · Jun 2018
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
K180616 · Contamac, Ltd. · Apr 2018
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG
K180172 · Paragon Vision Sciences · Mar 2018
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
K073184 · Bausch & Lomb, Inc. · Feb 2008
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
K071266 · Bausch & Lomb, Inc. · Aug 2007
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
K071043 · Bausch & Lomb, Inc. · Aug 2007