DEVICE: K-Laser (B317KCUBE0)

Device Identifier (DI) Information

K-Laser
K-Laser Cube
In Commercial Distribution

ELTECH KLASER SRL
B317KCUBE0
HIBCC

1
654931570 *Terms of Use
Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General therapeutic low-intensity laser, line-powered A mains electricity (AC-powered) diode laser intended to be used to provide low-level laser therapy (LLLT) for a variety of clinical applications (e.g., to treat pain, promote healing of wounds/injuries/disorders of the joints and soft/connective tissues, for non-needle acupuncture). It typically consists of an electronic control unit which may be mounted on a mobile (on wheels) trolley, with a connected applicator to generate laser light in the range of visible red/infrared frequencies (e.g., 650 – 685 nm, 660 - 980 nm). It is intended to be operated by a healthcare provider in a clinical setting.
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FDA Product Code

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Product Code Product Code Name
ILY Lamp, Infrared, Therapeutic Heating
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

992faf1c-c278-4640-9c9c-8ff6128b1379
March 29, 2018
2
September 06, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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