Cleared Traditional

K192749 - Dermadry

K192749 is an FDA 510(k) clearance for Dermadry, manufactured by Dermadry Laboratories, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

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

FDA 510(k) Submission Details - K192749

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.

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 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 55
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K192749.
STOPWET iontophoresis apparatus (SW01)
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Saalio
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IontoDC
K170291 · Soterix Medical, Inc. · May 2017