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ACTHYDERM

by Microlab Americas, Inc.

510(k) K083016

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083016 Date16 Jun 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EGJ
Device Class
Class II
Regulation
21 CFR Part 890.5525
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

ACTHYDERM is an iontophoresis device used for other purposes in physical medicine. It is a Class II medical device with product code EGJ that delivers active ingredients through the skin using a patented procedure called Mesoporation.

The device is manufactured by Microlab Americas, Inc. and received FDA 510(k) clearance on June 16, 2009, under regulation number 890.5525. It is supplied as a single-use device and is not indicated for MRI use. The device is stored at room temperature and is authorized for use in physical medicine applications.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is ACTHYDERM used for in physical medicine?

    ACTHYDERM is an iontophoresis device used for other purposes in physical medicine. It delivers active ingredients through the skin using a patented procedure called Mesoporation, making it suitable for various therapeutic applications in physical medicine settings.

  • Is ACTHYDERM a single-use device or can it be reused?

    ACTHYDERM is supplied as a single-use device and is not intended for reuse. This design ensures patient safety and prevents cross-contamination between different patients or treatment sessions.

  • What are the storage requirements for ACTHYDERM?

    ACTHYDERM should be stored at room temperature. Proper storage conditions help maintain the device's integrity and functionality until its intended use in physical medicine applications.

  • What regulatory clearance has ACTHYDERM received?

    ACTHYDERM received FDA 510(k) clearance on June 16, 2009, under regulation number 890.5525. It is classified as a Class II medical device with product code EGJ for use in physical medicine applications.