Cleared Traditional

K013762 - RIGID GAS PERMEABLE CONTACT LENS

K013762 is an FDA 510(k) clearance for RIGID GAS PERMEABLE CONTACT LENS, manufactured by Bausch & Lomb, Incorporated. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K013762 · Bausch & Lomb, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
141d
Days
Class 2
Risk

K013762 is an FDA 510(k) clearance for the RIGID GAS PERMEABLE CONTACT LENS. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on April 3, 2002 after a review of 141 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Bausch & Lomb, Incorporated devices

FDA 510(k) Submission Details - K013762

510(k) Number K013762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date April 03, 2002
Days to Decision 141 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 110d · This submission: 141d
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 82
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K013762.
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K033594 · Contamac, Ltd. · Mar 2004
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
K021977 · Contamac, Ltd. · Sep 2002
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K022128 · Bausch & Lomb, Incorporated · Aug 2002
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K011945 · Polymer Technology Corp. · Sep 2001
SPORTSIGHT GP
K993586 · Paragon Vision Sciences · May 2000
MENICON SF-P
K000233 · Menicon Co, Ltd. · May 2000