Cleared Traditional

K962934 - AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR

K962934 is an FDA 510(k) clearance for AIRPERM(SIFLUFOCON A) RIGID GAS PERMEAB..., manufactured by Airperm, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K962934 · Airperm, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
29d
Days
Class 2
Risk

K962934 is an FDA 510(k) clearance for the AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY.... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Airperm, Inc. (Sherman Oaks, US). The FDA issued a Cleared decision on August 27, 1996 after a review of 29 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 Airperm, Inc. devices

FDA 510(k) Submission Details - K962934

510(k) Number K962934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1996
Decision Date August 27, 1996
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
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 K962934.
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
K970698 · Polymer Technology Corp. · May 1997
LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K963010 · Permeable Technologies, Inc. · Nov 1996
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K962006 · Menicon Co, Ltd. · Oct 1996
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