Cleared Traditional

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE

K170835 · Hightech Development · Physical Medicine
Jun 2018
Decision
452d
Days
Class 2
Risk

About This 510(k) Submission

K170835 is an FDA 510(k) clearance for the Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE, a Device, Iontophoresis, Other Uses (Class II — Special Controls, product code EGJ), submitted by Hightech Development (Prague, CZ). The FDA issued a Cleared decision on June 15, 2018, 452 days after receiving the submission on March 20, 2017. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number K170835 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2017
Decision Date June 15, 2018
Days to Decision 452 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code EGJ — Device, Iontophoresis, Other Uses
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5525