Cleared Traditional

K935995 - HAND-HELD HEAT APPLICATOR

K935995 is an FDA 510(k) clearance for HAND-HELD HEAT APPLICATOR, manufactured by Avon Products, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K935995 · Avon Products, Inc. · Physical Medicine device
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Jun 1994
Decision
176d
Days
Class 2
Risk

K935995 is an FDA 510(k) clearance for the HAND-HELD HEAT APPLICATOR. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Avon Products, Inc. (New York, US). The FDA issued a Cleared decision on June 9, 1994 after a review of 176 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - 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 Avon Products, Inc. devices

FDA 510(k) Submission Details - K935995

510(k) Number K935995 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 15, 1993
Decision Date June 09, 1994
Days to Decision 176 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 - ILY Lamp, Infrared, Therapeutic Heating

All 156
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K935995.
WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS
K954577 · C.A.I. Industries Corp. · May 1997
THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
K963728 · China Chongqing Bashan Instrument Factory · Dec 1996
FIRARD II/ TDP LAMP
K960036 · Helio Medical Supplies, Inc. · Jun 1996
OLYMPIC WARM-LAMP
K932881 · Olympic Medical Corp. · Jan 1994