Trsansderm Ionto System

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

510(k) Number

K032968 ↗

FDA Product Code

EGJ

Device Class

Class II

Regulation

21 CFR Part 890.5525

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Multiple CO2 Laers

  Class II

  FDA 510(k) K941838 Active Cleared 15 Dec 1994

• Mattioli Pulse Two/Three Plus Family

  Class II

  FDA 510(k) K100053 Active Cleared 10 Mar 2010

• Dms-1000C Dermoabrader

  Class I

  FDA 510(k) K965256 Active Cleared 9 Dec 1996

• Transderm Ionto System, Mk 2

  Class II

  FDA 510(k) K042590 Active Cleared 14 Oct 2004

• What types of medical treatments can the TRSANSDERM IONTO System be used for, and why is iontophoresis preferred in these cases?

  The TRSANSDERM IONTO System is designed for the non-invasive delivery of ionic drug solutions through the skin using low-level electrical current, making it suitable for treatments involving high molecular weight compounds (up to 1 million Daltons). Iontophoresis is preferred in these cases because it enhances drug penetration without requiring injections or syringes, reducing patient discomfort and potential infection risks while enabling targeted transdermal administration under medical supervision.

• Is the TRSANSDERM IONTO System reusable, and if so, how should it be maintained to ensure proper functionality and sterility?

  Yes, the TRSANSDERM IONTO System is supplied as a reusable medical instrument. To maintain sterility and functionality, it must be stored according to regulatory standards outlined in 21 CFR 890.5525, and disposable electrodes should be used with each treatment to prevent cross-contamination. Follow manufacturer guidelines for cleaning and storage to ensure compliance and optimal performance.

• What regulatory pathway was followed for FDA clearance of the TRSANSDERM IONTO System, and what does this mean for its use in clinical settings?

  The TRSANSDERM IONTO System received FDA clearance under the 510(k) pathway, specifically determined to be *substantially equivalent* to existing devices in the Physical Medicine category. This means it was reviewed and approved as meeting the same performance standards as comparable iontophoresis devices already on the market, allowing its use in clinical settings under medical supervision for transdermal drug delivery.

• How does the TRSANSDERM IONTO System differ from other iontophoresis devices, and what makes it suitable for high-molecular-weight compounds?

  The TRSANSDERM IONTO System is designed to deliver ionic drug solutions through the skin using a controlled low-level electrical current, which enhances penetration—particularly for high-molecular-weight compounds (up to 1 million Daltons). Unlike some other iontophoresis devices, its engineering focuses on targeted transdermal administration without injections, making it ideal for clinical treatments where precision and non-invasive delivery are critical.

• What storage requirements apply to the TRSANSDERM IONTO System to ensure its sterility and proper functionality?

  The system must be stored in accordance with 21 CFR 890.5525 to maintain sterility and functionality. Since it is reusable, proper cleaning and storage protocols must be followed to prevent contamination. Additionally, disposable electrodes should be used per each treatment to uphold regulatory standards and ensure safe, effective operation.