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510(k) Data Aggregation
K Number
K080786Device Name
ML830TP
Manufacturer
MICROLIGHT CORPORATION OF AMERICA
Date Cleared
2008-10-03
(197 days)
Product Code
ILY, INF
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
MICROLIGHT CORPORATION OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ML830®TP is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscles.
Device Description
The ML830 TP is a non-invasive, easy to use hand-held therapeutic device consisting of a probe containing battery-powered electronics that activate a single diode which delivers infrared energy. The probe is intended to be placed on or near the surface of the skin to provide temporary relief from pain.
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K Number
K041364Device Name
ML830 LASER SYSTEM
Manufacturer
MICROLIGHT CORPORATION OF AMERICA
Date Cleared
2004-12-13
(206 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
MICROLIGHT CORPORATION OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroLight ML830 d contains infrared lamps that are indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature: for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxtion of pain, artifitis and inuscle spassily increase local blood circulation where applied.
Device Description
The ML830®d is an innovative, safe, easy to use, hand-held, non-invasive device The ML830 u is an innovative, sare, easy es approximately % pound and has a designed for in-nonic use. "The device worgine upper of these (34 square centimeters).
The ML830®d contains 12 light emitting diodes and 12 infrared diodes with The NILGSV a commits TF ingile change
wavelengths of 660 nanometers, and 880 nanometers, respectively, with total or waverongais of approximately 500 milliwatts.
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K Number
K010175Device Name
MICROLIGHT 830 LASER SYSTEM
Manufacturer
MICROLIGHT CORPORATION OF AMERICA
Date Cleared
2002-02-06
(384 days)
Product Code
NHN
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
MICROLIGHT CORPORATION OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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