Cleared Special

K062548 - MODIFICATION TO OPTIMUM GP (OXYGEN PERM...

K062548 is an FDA 510(k) clearance for MODIFICATION TO OPTIMUM GP (OXYGEN PERM..., manufactured by Contamac, Ltd.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Special 510(k) pathway after a 63-day FDA review.

K062548 · Contamac, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
63d
Days
Class 2
Risk

K062548 is an FDA 510(k) clearance for the MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Contamac, Ltd. (Grand Junction, US). The FDA issued a Cleared decision on November 1, 2006 after a review of 63 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Contamac, Ltd. devices

FDA 510(k) Submission Details - K062548

510(k) Number K062548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2006
Decision Date November 01, 2006
Days to Decision 63 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 34
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K062548.
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
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K013762 · Bausch & Lomb, Incorporated · Apr 2002