FDA.reportPublic FDA data

528i

Primary DI
G6815H11000
Brand
528i
Company
528 Innovations LLC
Model
5i Series Laser Therapy Handset
Catalog number
5H1100
Device description
5i Series Laser Therapy Handset (device) with bluetooth connectivity and user interface
Published
2025-03-01
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
G6815H11000PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
849568154
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G6815B11000528i5i Series Rechargeable Battery5B11002025-03-01
G6815L11000528i5i Series 808nm Laser Module5L11002025-03-01
G6815L21000528i5i Series 975nm Laser Module5L21002025-03-01

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Primary DI, Brand, Company table
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