Cleared Traditional

Dermadry

K192749 · Dermadry Laboratories, Inc. · Physical Medicine

Feb 2020

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K192749 is an FDA 510(k) clearance for the Dermadry, a Device, Iontophoresis, Other Uses (Class II — Special Controls, product code EGJ), submitted by Dermadry Laboratories, Inc. (Montreal, CA). The FDA issued a Cleared decision on February 10, 2020, 133 days after receiving the submission on September 30, 2019. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number	K192749 FDA.gov
FDA Decision	Cleared 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