Cleared Traditional

K003538 - TDP CQ-27 HEAT LAMP

K003538 is an FDA 510(k) clearance for TDP CQ-27 HEAT LAMP, manufactured by Lhasa Medical, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K003538 · Lhasa Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
200d
Days
Class 2
Risk

K003538 is an FDA 510(k) clearance for the TDP CQ-27 HEAT LAMP. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Lhasa Medical, Inc. (Weymouth, US). The FDA issued a Cleared decision on June 4, 2001 after a review of 200 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.

FDA 510(k) Submission Details - K003538

510(k) Number K003538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2000
Decision Date June 04, 2001
Days to Decision 200 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 116d · This submission: 200d
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 220
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K003538.
SSIR SYSTEM
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MU PHOTONICS PAIN THERAPIST
K012508 · Nu Photonics, Inc. · Oct 2001
SUPER NOVA, ACUBEAM
K001179 · Light Force Therapy, Inc. · Oct 2000
OLYMPIC WARM-UP
K001056 · Olympic Medical Corp. · Sep 2000
SPINAL PAD
K993684 · Bioscan, Inc. · Jul 2000
K003538 · TDP CQ-27 HEAT LAMP
Download PDF FDA Summary Lhasa Medical, Inc.