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K Number
K003538
Device Name
TDP CQ-27 HEAT LAMP
Manufacturer
LHASA MEDICAL, INC.
Date Cleared
2001-06-04

(200 days)

Product Code
ILY
Regulation Number
890.5500
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
K020851,K024179,K043558,K050397,K052063,K061080,K080465,K110721
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.