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510(k) Data Aggregation
K Number
K152461Device Name
The Time Machine Series Lasers
Manufacturer
MEDICAL LASERS MANUFACTURER INC.
Date Cleared
2016-07-08
(315 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL LASERS MANUFACTURER INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Time Machine Series Lasers Model TTML-8102000 - 810/830 nm is intended for use in temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.
Device Description
The TTML-8102000 hand held laser device operates in continuous wave mode at a fixed frequency. The Power is operated with lithium batteries. A cap covers the laser aperture and must be removed before treatment. Activating a mechanical button powers on the unit when operating by battery power. When a mechanical switch is pressed a LCD screen illuminates. The device can be operated in either of two modes which are selected by means of a mechanical switch: (1) a timer mode where treatment time is entered by means of a mechanical switch and time is displayed on the LCD screen. The device automatically shuts off when the set time is reached. (2) a manual mode where treatment continues until the device is manually shut off. The unit is powered down by pressing the power button (battery mode). None of these functions are controlled by software. The software controls only the timer and time display. Software is embedded into a single chip circuit which contains the CPU and memory. These chips are used in simple circuits. The device can maintain skin temperature of 40-45℃ for at least 10 minutes based on the study conducted on three live human subject.
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