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510(k) Data Aggregation
K Number
K150466Device Name
ZX2 Laser System
Manufacturer
Date Cleared
2015-06-08
(105 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
LZR7, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ZX2 Laser System is intended 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 and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
Device Description
The ZX2 Laser System is a non-invasive, low energy, infrared therapeutic medical laser. The ZX2 Laser incorporates an AC Control Unit and a variety of hand-held laser probes. The Control Unit has two (2) completely independent probe outputs which allow use of the device by two operators at once and/or treatment using two probes at once.
The Control Unit houses the power supply, electronics and user interface panel. The Control Unit is connected to a suitable grounded outlet. The Control Unit is equipped with a key which when inserted into the switch the Unit can be activated. The ZX2 has an emergency stop button that, when pressed, will deactivate the device. The device houses a split screen panel on the face of the control unit and dual control buttons for use with two independent probes.
The hand-held probes that are optional with the ZX2 Laser System include:
1. 750 mW Deep Probe 808 nm GaAlAs Semiconductor laser
2. 1.5 W Deep Probe 808 nm GaAlAs Semiconductor laser
3. 6.1 W Multi Probe 808 nm GaAlAs Semiconductor laser / 658 nm Ga Aa InP
4. SP4 Probe 904 nm Ga As Semiconductor Laser Pulsed
The above laser probes incorporate laser diode/s at 658nm, 808nm and 904nm diodes, classifying it under 21 CFR 890.5500, ILY infrared lamp for adjunctive use in pain therapy.
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