Cleared Traditional

K002025 - RIGID GAS PERMEABLE CONTACT LENS

K002025 is an FDA 510(k) clearance for RIGID GAS PERMEABLE CONTACT LENS, manufactured by Polymer Technology. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K002025 · Polymer Technology · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
120d
Days
Class 2
Risk

K002025 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 Polymer Technology (Rochester, US). The FDA issued a Cleared decision on October 31, 2000 after a review of 120 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 Polymer Technology devices

FDA 510(k) Submission Details - K002025

510(k) Number K002025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2000
Decision Date October 31, 2000
Days to Decision 120 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
10d slower than avg
Panel avg: 110d · This submission: 120d
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 K002025.
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K022128 · Bausch & Lomb, Incorporated · Aug 2002
RIGID GAS PERMEABLE CONTACT LENS
K013762 · Bausch & Lomb, Incorporated · Apr 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
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR
K992787 · Specialty Ultravision, Inc. · Feb 2000