DEVICE: Platinum (B679SLP30)

Device Identifier (DI) Information

Platinum
SLP3
In Commercial Distribution
SLP3
SUMMUS MEDICAL LASER, LLC
B679SLP30
HIBCC

1
621560338 *Terms of Use
Light weight (~2 Kg.) and portable therapeutic medical laser device (measuring ~225 mm x 150 mm x 150 mm) indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments are in the form of non-ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60409 Musculoskeletal/physical therapy laser, professional
An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.
Active false
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FDA Product Code

[?]
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
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 35 Degrees Celsius
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2b2860b7-de5b-4e2b-974d-56f52839a0c5
December 08, 2022
15
August 14, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
(404) 815-1505
drtaylor@fidelityatlanta.com
(949) 650-0736
drryan@backtobasicsnewport.com
(408) 999-5866
rtufts@sjsharks.com
239 246 2920
angie@gearedup.biz
(253) 474-9670
jstack6@aol.com
(763) 856-4848
doctorkrenz@gmail.com
(715) 246-5606
countrysidevet@frontiernet.net
(256) 739-0140
lisaweeks01@bellsouth.net
615-595-7749
info@fizian.si
(615) 595-7749
info@sixtus.it
(615) 595-7749
drhealthymood@gmail.com
(615) 595-7749
konrad.tagwerker@elanus-medical.com
615-595-7749
info@sixtus.it
(615) 595-7749
cs@trimaxhealthcare.com
615-595-7749
info@elanus-medical.com
(615) 595-7749
massimo.marrucci@sixtus.it
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