Cleared Traditional

K060924 - JSZ MULTIACTION GP CONTACT LENS SOLUTION

K060924 is an FDA 510(k) clearance for JSZ MULTIACTION GP CONTACT LENS SOLUTION, manufactured by Szabocsik and Associates. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K060924 · Szabocsik and Associates · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
85d
Days
Class 2
Risk

K060924 is an FDA 510(k) clearance for the JSZ MULTIACTION GP CONTACT LENS SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Szabocsik and Associates (Chicago, US). The FDA issued a Cleared decision on June 28, 2006 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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.

FDA 510(k) Submission Details - K060924

510(k) Number K060924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2006
Decision Date June 28, 2006
Days to Decision 85 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
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LPN Accessories, Soft Lens Products

All 119
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K060924.
EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION
K070767 · Lapis Lazuli International NV · Jul 2007
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
K071203 · Optikem International, Inc. · Jun 2007
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
K062332 · Altaire Pharmaceuticals, Inc. · Apr 2007
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
K051104 · Lapis Lazuli, NV · May 2006
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
K050729 · Alcon Research, Ltd. · Sep 2005
AQUIFY MULTIPURPOSE SOLUTION
K050250 · Ciba Vision Corporation · Aug 2005
K060924 · JSZ MULTIACTION GP CONTACT LENS SOLUTION
Download PDF FDA Summary Szabocsik and Associa…