FDA.reportPublic FDA data

Laserconn

Primary DI
06972558160021
Brand
Laserconn
Company
Sanhe Laserconn Tech Co., Ltd.
Model
Theralas
Catalog number
Laser Therapy System
Device description
Diode laser is intended to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, temporary increase local blood circulation and promoting relaxation of muscle
Published
2021-06-28
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
16972558160028PackageGS11In Commercial Distribution
06972558160021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697255816002816972558160028
06972558160021069725581600216972558160021

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), 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height264.58Micrometer
Length462.5Micrometer
Width368Micrometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
17729996108ge@3dstocking.com

Regulatory Flags#

DUNS number
560439500
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
06972558160038LaserconnMilestone Smart-MDiode Laser Hair Removal System2022-12-13
06972558160045LaserconnMilestone Standard-ADiode Laser Hair Removal System2022-12-13
16972558160028LaserconnTheralasLaser Therapy System2021-06-28

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Primary DI, Brand, Company table
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