Cleared Traditional

K002703 - O-PERM 30

K002703 is an FDA 510(k) clearance for O-PERM 30, manufactured by Optical Polymer Research, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K002703 · Optical Polymer Research, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
83d
Days
Class 2
Risk

K002703 is an FDA 510(k) clearance for the O-PERM 30. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Optical Polymer Research, Inc. (Gainesville, US). The FDA issued a Cleared decision on November 21, 2000 after a review of 83 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 Optical Polymer Research, Inc. devices

FDA 510(k) Submission Details - K002703

510(k) Number K002703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2000
Decision Date November 21, 2000
Days to Decision 83 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 110d · This submission: 83d
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 72
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K002703.
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