FDA.reportPublic FDA data

LZR7

Primary DI
B657002
Brand
LZR7
Company
LZR7, INC.
Model
Pro3M
Device description
Pro3M Laser Unit
Published
2019-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B657002PrimaryHIBCC0

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), improving blood circulation in the treated areas to facilitate healing, 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 healthcare provider in both a clinical setting and in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116912256
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B657003LZR7Ultrabright2020-07-25
B657001LZR7ZX22019-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
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B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
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B347TB202400000TABLED TECHNOLOGIES INCILY2026-04-23
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B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
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G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
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