Cleared Traditional

K944223 - ACCUCON

K944223 is an FDA 510(k) clearance for ACCUCON, manufactured by Innovision, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K944223 · Innovision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
99d
Days
Class 2
Risk

K944223 is an FDA 510(k) clearance for the ACCUCON. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Innovision, Inc. (Omaha, US). The FDA issued a Cleared decision on December 7, 1994 after a review of 99 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 Innovision, Inc. devices

FDA 510(k) Submission Details - K944223

510(k) Number K944223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1994
Decision Date December 07, 1994
Days to Decision 99 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
11d faster than avg
Panel avg: 110d · This submission: 99d
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 42
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K944223.
RIGID GAS PERMEABLE CONTACT LENS
K013762 · Bausch & Lomb, Incorporated · Apr 2002
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K011945 · Polymer Technology Corp. · Sep 2001
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
K970698 · Polymer Technology Corp. · May 1997
BOSTON(R) 7 - 30(ENFLUFOCON A)
K943177 · Polymer Technology Corp. · Aug 1994
BOSTON VII
K942365 · Polymer Technology Corp. · Jun 1994