Cleared Traditional

K954124 - O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS

K954124 is an FDA 510(k) clearance for O-PERM 30 A RIGID GAS PERMEABLE CONTACT..., 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 200-day FDA review.

K954124 · Optical Polymer Research, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
200d
Days
Class 2
Risk

K954124 is an FDA 510(k) clearance for the O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Optical Polymer Research, Inc. (Rosewell, US). The FDA issued a Cleared decision on March 19, 1996 after a review of 200 days - an extended review 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: 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 Optical Polymer Research, Inc. devices

FDA 510(k) Submission Details - K954124

510(k) Number K954124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date March 19, 1996
Days to Decision 200 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
90d slower than avg
Panel avg: 110d · This submission: 200d
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 71
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K954124.
NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY
K960584 · Novavision, Inc. · Aug 1996
TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS
K955366 · Rand Scientific Corp. · Mar 1996
NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR
K955900 · Novavision, Inc. · Mar 1996
OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
K952260 · Stellar Contact Lens, Inc. · Jan 1996
MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR
K943784 · Menicon Co, Ltd. · Oct 1994
BOSTON(R) 7 - 30(ENFLUFOCON A)
K943177 · Polymer Technology Corp. · Aug 1994