Cleared Traditional

K900363 - NEOPHOR-MC

K900363 is an FDA 510(k) clearance for NEOPHOR-MC, manufactured by L.S. Scientific. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K900363 · L.S. Scientific · Physical Medicine device
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Apr 1990
Decision
90d
Days
Class 2
Risk

K900363 is an FDA 510(k) clearance for the NEOPHOR-MC. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by L.S. Scientific (Riverside, US). The FDA issued a Cleared decision on April 25, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all L.S. Scientific devices

FDA 510(k) Submission Details - K900363

510(k) Number K900363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received January 25, 1990
Decision Date April 25, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGJ Device Classification - Class 2, Special Controls

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - EGJ Device, Iontophoresis, Other Uses

All 45
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K900363.
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