Santa Barbara Medco-Lantophoretic Applic

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

510(k) Number

K842483 ↗

FDA Product Code

EGJ

Device Class

Class II

Regulation

21 CFR Part 890.5525

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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See all devices from Santa Barbara Medco, Inc. →

• What is the primary purpose of the Santa Barbara Medco Lantophoretic Applicator and how does it work?

  The Santa Barbara Medco Lantophoretic Applicator is designed for transdermal delivery of medications or substances using low-level electrical current (iontophoresis). It helps therapeutic agents penetrate deeper skin layers for localized treatment, commonly used in physical medicine applications like wound care, pain management, or inflammation reduction. The device applies a controlled electric current to facilitate ion movement through the skin, enhancing absorption of applied substances.

• Is this device intended for single-use or reusable applications, and what maintenance is required?

  The Santa Barbara Medco Lantophoretic Applicator is reusable and intended for use in clinical settings. Since it is not sterile as supplied, proper cleaning, disinfection, and maintenance per the manufacturer’s guidelines are required between uses to ensure safety and functionality. Always follow the manufacturer’s instructions to prevent cross-contamination or device damage.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The device received FDA 510(k) clearance (K842483) under the Traditional 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate. It is classified as a Class II device under the Iontophoresis and Other Uses category (product code EGJ), regulated under 21 CFR 890.5525 for physical medicine applications. The review was conducted by the Physical Medicine (PM) Advisory Committee.

• Are there multiple models or sizes available for this applicator, and how should it be stored?

  The provided data lists multiple FEI (Final Establishment Identification) numbers, which may correspond to different models or configurations of the device, though specific sizes or variations are not detailed. Storage instructions are not explicitly stated, but reusable medical devices should generally be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain functionality and hygiene.