Cleared Traditional

K050517 - JSZ-MULTIPURPOSE SOLUTION

K050517 is an FDA 510(k) clearance for JSZ-MULTIPURPOSE 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 43-day FDA review.

K050517 · Szabocsik and Associates · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
43d
Days
Class 2
Risk

K050517 is an FDA 510(k) clearance for the JSZ-MULTIPURPOSE 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 April 13, 2005 after a review of 43 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 - K050517

510(k) Number K050517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2005
Decision Date April 13, 2005
Days to Decision 43 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
67d faster than avg
Panel avg: 110d · This submission: 43d
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 K050517.
AQUIFY MULTIPURPOSE SOLUTION
K050250 · Ciba Vision Corporation · Aug 2005
LENS PLUS REWETTING DROPS
K042562 · Advanced Medical Optics, Inc. · Jul 2005
EYE-CEPT REWETTING DROPS
K041008 · Optics Laboratory, Inc. · Jul 2005
AQUIFY LENS COMFORT DROPS
K042176 · Ciba Vision Corporation · Nov 2004
KARATS MULTIPURPOSE SOLUTION
K031753 · Ciba Vision Corporation · Oct 2004
AQUIFY MULTI-PURPOSE SOLUTION
K033608 · Ciba Vision Corporation · Feb 2004
K050517 · JSZ-MULTIPURPOSE SOLUTION
Download PDF FDA Summary Szabocsik and Associa…