Cleared Traditional

K083016 - ACTHYDERM

K083016 is an FDA 510(k) clearance for ACTHYDERM, manufactured by Microlab Americas, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K083016 · Microlab Americas, Inc. · Physical Medicine device
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Jun 2009
Decision
250d
Days
Class 2
Risk

K083016 is an FDA 510(k) clearance for the ACTHYDERM. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Microlab Americas, Inc. (Crofton, US). The FDA issued a Cleared decision on June 16, 2009 after a review of 250 days - an extended review cycle.

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 Microlab Americas, Inc. devices

FDA 510(k) Submission Details - K083016

510(k) Number K083016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2008
Decision Date June 16, 2009
Days to Decision 250 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 115d · This submission: 250d
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 43
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K083016.
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HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
K072946 · Empi · Nov 2007
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K070427 · Empi · May 2007