DEVICE: Platinum (B679KP30)
Device Identifier (DI) Information
Platinum
KP3
Not in Commercial Distribution
KP3
SUMMUS MEDICAL LASER, LLC
KP3
Not in Commercial Distribution
KP3
SUMMUS MEDICAL LASER, LLC
Therapeutic medical laser device 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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ILY | Lamp, Infrared, Therapeutic Heating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 35 Degrees Celsius |
Storage Environment Temperature: between 0 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fcafdc0a-4c59-45a2-921e-721cc3bad436
January 10, 2025
10
August 16, 2018
January 10, 2025
10
August 16, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
408-396-8069
wleonardsjbarracuda@gmail.com 636-928-5588
crosbychiropractic@gmail.com 716-623-3425
chirodan20roadrunner@gmail.com 517-235-3276
jwinseck@hotmail.com 731-588-5144
performchirotn@gmail.com 808-557-3540
lokenanisouza@gmail.com 302-355-0056
emgoody79@gmail.com 714-669-8760
dr.bonnieactivechiropractic@gmail.com 330-671-1976
erica@azulwell.com 812-363-5634
drbjwallpe@gmail.com 573-808-2413
mjtellor1@gmail.com 303-598-1999
jon@denversportsdoc.com 707-889-0995
drlaura@pulsewave.com 714-267-2220
drstevendunbar@yahoo.com 636-227-2100
laney.nelson@logan.edu 423-954-7661
docwarlick@gmail.com 972-930-9566
shuch1@yahoo.com 602-909-8287
jenniferhallquist@hotmail.com 408-999-5866
rtufts@sjsharks.com 239-513-0055
regenerative.email@gmail.com 312-579-3150
performancepodiatry.email@gmail.com (408) 396-8069
wleonard@sjbarracuda.com
wleonardsjbarracuda@gmail.com 636-928-5588
crosbychiropractic@gmail.com 716-623-3425
chirodan20roadrunner@gmail.com 517-235-3276
jwinseck@hotmail.com 731-588-5144
performchirotn@gmail.com 808-557-3540
lokenanisouza@gmail.com 302-355-0056
emgoody79@gmail.com 714-669-8760
dr.bonnieactivechiropractic@gmail.com 330-671-1976
erica@azulwell.com 812-363-5634
drbjwallpe@gmail.com 573-808-2413
mjtellor1@gmail.com 303-598-1999
jon@denversportsdoc.com 707-889-0995
drlaura@pulsewave.com 714-267-2220
drstevendunbar@yahoo.com 636-227-2100
laney.nelson@logan.edu 423-954-7661
docwarlick@gmail.com 972-930-9566
shuch1@yahoo.com 602-909-8287
jenniferhallquist@hotmail.com 408-999-5866
rtufts@sjsharks.com 239-513-0055
regenerative.email@gmail.com 312-579-3150
performancepodiatry.email@gmail.com (408) 396-8069
wleonard@sjbarracuda.com