M-Hi US

GUDID 08033765391702

The M-Hi US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.

ASA SRL

Musculoskeletal infrared phototherapy unit, non-wearable
Primary Device ID08033765391702
NIH Device Record Key3bf24fd7-6f10-492f-a8f8-f6d3a06261ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameM-Hi US
Version Model NumberF9000296
Company DUNS429533573
Company NameASA SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033765391702 [Primary]

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-09
Device Publish Date2024-07-01

Devices Manufactured by ASA SRL

08033765391726 - MiS US2025-05-26 The MiS US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatmen
08033765391764 - Lumolaser2025-05-26 The Lumolaser is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treat
08033765391009 - ASA srl2025-04-18
08033765391016 - ASA srl2025-04-18
08033765391023 - ASA srl2025-04-18
08033765391054 - M82025-04-18
08033765391207 - Mphi 72025-04-18 The Mphi 7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatmen
08033765391757 - HIRO TT US2025-02-27 The HIRO TT US is an electrically-powered Nd:YAG laser intended to provide non-surgical infrared laser therapy for localized tre
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