FDA.reportPublic FDA data

PowerLaser Pro1200 Red

Primary DI
05713592451253
Brand
PowerLaser Pro1200 Red
Company
Powermedic ApS
Model
45125
Published
2023-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
05713592451253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713592451253057135924512535713592451253

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, home-useAn electrically-powered diode laser intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, rheumatism, disorders of the joints and soft/connective tissues), improvement of local blood/lymph circulation to facilitate healing/reduce swelling (e.g., lymphoedema therapy), or for non-needle acupuncture. It typically consists of a hand-held applicator designed for transcutaneous delivery of visible red/infrared laser light energy. It is intended to be operated by a patient/layperson in the home, typically under healthcare professional guidance.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305378978
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713592301824PowerLaser Basic1800 Vet Cool Grey301822024-03-26
05713592301831PowerLaser Basic1800 Vet Olive Green301832024-03-26
05713592301848PowerLaser Basic1800 Vet Platinum301842024-03-26
05713592030120PowerLaser Basic120030122022-01-25
05713592400558PowerLaser Pro500 VET Red400552023-10-16
05713592401555PowerLaser Pro1500 VET Red401552023-10-16
05713592451215PowerLaser Pro1200 Black451212023-10-16
05713592500104PowerLaser Pro1200 White451262023-10-16
05713592622103GigaLaser GL1801 Screenmodule622102023-10-16
05713592301640PowerLaser Basic1600 VET Platinum301642023-09-13
57135920301529PowerLaser Basic Vet1500 Cool Grey301522023-06-13
57135920222503GigaLaser GL1801 RB222502023-06-14
57135920300522PowerLaser Basic Vet500 Cool Grey300522023-06-13
57135920300539PowerLaser Basic Vet500 Olive Green300532023-06-13
57135920300546PowerLaser Basic Vet500 Platinum300542023-06-13
57135920301222PowerLaser Basic Vet1200 Cool Grey301222023-06-13
57135920301239PowerLaser Basic Vet1200 Olive Green301232023-06-13
57135920301246PowerLaser Basic Vet1200 Platinum301242023-06-13
57135920301536PowerLaser Basic Vet1500 Olive Green301532023-06-13
57135920301543PowerLaser Basic Vet1500 Platinum301542023-06-13

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