Cleared Traditional

Dermadry (K192749) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192749 · Dermadry Laboratories, Inc. · Physical Medicine device
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Feb 2020
Decision
133d
Days
Class 2
Risk

K192749 is an FDA 510(k) clearance for the Dermadry. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Dermadry Laboratories, Inc. (Montreal, CA). The FDA issued a Cleared decision on February 10, 2020 after a review of 133 days - within the typical 510(k) review window.

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 Dermadry Laboratories, Inc. devices

Submission Details

510(k) Number K192749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date February 10, 2020
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Lok North America, Inc.
Louis-Paul Marin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EGJ Device, Iontophoresis, Other Uses

All 72
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K192749.
STOPWET iontophoresis apparatus (SW01)
K242041 · Taiwan Medical Electronics Co., Ltd. · Apr 2025
Hidroxa SE30
K241267 · Hidroxa Medical AB · Oct 2024
Iontophoresis Electrodes
K232020 · Top-Rank Health Care Co., Ltd. · Oct 2023
Saalio
K191436 · Saalmann Medical GmbH & Co. KG · Oct 2019
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
K170835 · Hightech Development · Jun 2018
TULA Iontophoresis System with Earset
K150453 · Acclarent, Inc. · May 2015