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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 116d · 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 69
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K083016.
HIDREX PSP1000
K133033 · Hidrex GmbH · Apr 2015
ACTIVAPATCH ET IONTOPHORESIS PATCH
K132832 · Activatek, Inc. · Feb 2014
TULA IONTOPHORESIS SYSTEM
K110636 · Acclarent, Inc. · Jun 2011
ACTIVAPATCH
K091326 · Activatek, Inc. · May 2009
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
K080580 · Axelgaard Mfg. Co., Ltd. · Jun 2008
IONTOPHORESIS SYSTEM
K073276 · Acclarent, Inc. · Mar 2008
K083016 · ACTHYDERM
Download PDF FDA Summary Microlab Americas, In…