Cleared Traditional

K170835 - Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE (FDA 510(k) Clearance)

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

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

K170835 is an FDA 510(k) clearance for the Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspir.... Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Hightech Development (Prague, CZ). The FDA issued a Cleared decision on June 15, 2018 after a review of 452 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Hightech Development devices

Submission Details

510(k) Number K170835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
337d slower than avg
Panel avg: 115d · This submission: 452d
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 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 K170835.
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
Dermadry
K192749 · Dermadry Laboratories, Inc. · Feb 2020
TULA Iontophoresis System with Earset
K150453 · Acclarent, Inc. · May 2015