FDA.reportPublic FDA data

SH1

Primary DI
08057017760207
Brand
SH1
Company
EL.EN. SPA
Model
M077H3
Catalog number
M077H3
Device description
The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG laser sources.
Published
2016-09-13
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122125000ASA LASER SH1El.En Electronic Engineering Spa2013-01-25ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057017760207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057017760207080570177602078057017760207

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableAn electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436887608
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057017760979EXIRAM126AC12026-02-16
08057017760962LUVOM117H12025-11-24
08057017760221DEKA Motus AXM112B1M112B12017-07-03
08057017760337DEKA Minisilk FTM081R1M081R12018-04-16
08057017760443Thermaeye PlusM081AN1M081AN12021-10-19
08057017760559ECHOLASER X4M095H1M095H12021-05-07
08057017760504ECHOLASER X4M095G1M095G12020-02-14
08057017760320ECHOLASER X4M095D1M095D12020-01-15
08057017760214DEKA HIRO 3.0M080K1M080K12016-09-13
08057017760498DEKA PHYSIQM120F1M120F12020-01-15
08057017760528DEKA SMARTPERIOM128A1M128A12022-04-05
08057017760856NIRVANAM117H12024-04-18
08057017760818ALLORA PROM126AC12024-02-14
08057017760726DEKA SmartXide UltraSpeed 2M110F12023-04-27
08057017760535DEKA PHYSIQM120F1M120F12020-12-11
08057017760719DEKA SCULPTM116H1M116H12023-04-27
08057017760733DEKA TRUISTM117B1M117B12023-04-27
08057017760665DEKA HELIXM133A1M133A12023-03-21
08057017760108DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4M104K1M104K12016-09-13
08057017760115DEKA SYNCHRO REPLA:Y EXCELLIUM HPM104L1M104L12016-09-13

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Primary DI, Brand, Company table
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