Platinum

Primary DI
B679SLP4H0
Brand
Platinum
Company
SUMMUS MEDICAL LASER, LLC
Model
P4H
Catalog number
SLP4H
Device description
Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, 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 (Continuous Wave - CW power 28W and Intense Super Pulse - ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) 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.
Published
2020-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B679SLP4H0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, professionalAn 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), improving 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 internal (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated by a healthcare professional exclusively in a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(770) 428-4909mariettachiropractic@gmail.com
(951) 817-9815drrichter@prodigy.net
(815) 263-1360contactgoldorado@gmail.com
(704) 791-2366drericlkn@gmail.com
(904) 389-1010kramarich@riversidespine.com
(678) 697-4771IGNITECHIRO22@gmail.com
(408) 805-4325info@mindflowchiropractice.com
(240) 687-1414drcarr@marylandexotics.com
(410) 867-0770vickilin@verizon.net
(651) 484-3331mvhteam@mnvet.com
(978) 821-9014drshellyking@gmail.com
(843) 754-4231Wbr215@gmail.com
(678) 333-3751drkristina@elitetotalwellness.com
(864) 223-2663drchuck123@gmail.com
(417) 742-2617wfcadrkim@gmail.com
(989) 297-7215guilebar@gmail.com
(803) 788-8831office@columbiafamilychiro.com
(684)292-7756drlowery@blueridgefamilychiropractic.com
972-355-0083drstann@epichealthfm.com
(318) 395-2273jonesboroanimalclinic@gmail.com

Regulatory Flags#

DUNS number
621560338
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B679KGH10PlatinumKGH1KGH12019-06-27
B679KP30PlatinumKP3KP32018-08-16
B679KP40PlatinumKP4KP42018-08-16
B679SLH10PlatinumSLH1SLH12019-08-14
B679SLP40PlatinumSLP4SLP42019-08-14
B679SLP10PlatinumSLP1SLP12019-08-14
B679SLP30PlatinumSLP3SLP32019-08-14
B679KP10PlatinumKP1KP12018-08-16

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