Cleared Traditional

K863166 - MODEL 6110 IONTOPHORETIC APPLICATOR

K863166 is the FDA 510(k) clearance for MODEL 6110 IONTOPHORETIC APPLICATOR by Life-Tech Intl., Inc.. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K863166 · Life-Tech Intl., Inc. · Physical Medicine device
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Mar 1987
Decision
198d
Days
Class 2
Risk

K863166 is an FDA 510(k) clearance for the MODEL 6110 IONTOPHORETIC APPLICATOR. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on March 4, 1987 after a review of 198 days - an extended review cycle.

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 Life-Tech Intl., Inc. devices

Submission Details

510(k) Number K863166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1986
Decision Date March 04, 1987
Days to Decision 198 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 115d · This submission: 198d
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 27
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K863166.
XOMED IONESTHETIZER(TM)
K884834 · Xomed, Inc. · Feb 1989
MEDITRODE KIT
K882554 · Life-Tech Intl., Inc. · Dec 1988
MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
K871869 · Life-Tech Intl., Inc. · Aug 1987
IONTOPHORESIS SYSTEM MODULE, DM 500
K770717 · Sorensen Research · Aug 1977
DESENSITRON
K771130 · Parker Laboratories, Inc. · Jul 1977