Cleared Traditional

K963010 - LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR

K963010 is an FDA 510(k) clearance for LIFESTYLE GP (TELEFOCON B) RIGID GAS PE..., manufactured by Permeable Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K963010 · Permeable Technologies, Inc. · Ophthalmic device
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Nov 1996
Decision
110d
Days
Class 2
Risk

K963010 is an FDA 510(k) clearance for the LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DA.... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Permeable Technologies, Inc. (Colts Neck, US). The FDA issued a Cleared decision on November 20, 1996 after a review of 110 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 Permeable Technologies, Inc. devices

FDA 510(k) Submission Details - K963010

510(k) Number K963010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1996
Decision Date November 20, 1996
Days to Decision 110 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 110d · This submission: 110d
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 K963010.
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL
K963512 · Benz Research and Development Corp. · Jul 1997
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K963744 · Benz Research and Development Corp. · Jul 1997
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K970698 · Polymer Technology Corp. · May 1997
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K962006 · Menicon Co, Ltd. · Oct 1996
AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR
K962934 · Airperm, Inc. · Aug 1996
NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY
K960584 · Novavision, Inc. · Aug 1996