Cleared Traditional

K170835 - Electro Antiperspirant

K170835 is the FDA 510(k) clearance for Electro Antiperspirant by Hightech Development. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 452-day FDA review.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Insight, Inc.
Kevin Walls

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 8
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K170835.
Iontophoresis Electrodes
K232020 · Top-Rank Health Care Co., Ltd. · Oct 2023
Dermadry
K192749 · Dermadry Laboratories, Inc. · Feb 2020
Saalio
K191436 · Saalmann Medical GmbH & Co. KG · Oct 2019
TULA Iontophoresis System with Earset
K150453 · Acclarent, Inc. · May 2015
XOMED IONESTHETIZER(TM)
K884834 · Xomed, Inc. · Feb 1989
IONTOPHORESIS SYSTEM MODULE, DM 500
K770717 · Sorensen Research · Aug 1977