FDA.reportPublic FDA data

Soli-Lite LG2 Spectra

Primary DI
00667259001952
Brand
Soli-Lite LG2 Spectra
Company
Silhouet-Tone Corporation
Model
411560
Published
2018-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00667259001952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00667259001952006672590019526672590019520667259001952

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableA mains electricity (AC-powered) device intended 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-340-9456info@silhouettone.com

Regulatory Flags#

DUNS number
242049828
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00667259004007Laguna Edge (2M)4120052025-11-12
00667259003963EVOLUTION XHD4110272025-07-09
00667259003970EVOLUTION ST3504111032025-07-09
00667259001600PR Cell 2G4113212018-08-24
00667259003871ELITE PLATINUM LINAK (BI-V)4122682022-07-19
00667259001563ST2504111012018-08-24
00667259003796EVOLUTION 7HD SEQUENTIAL4110172018-09-17
00667259003901ELITE SERIE MD-100 W/O Accessories Table4122522021-09-09
00667259003918ELITE SERIE MD-100-With 2 Arm Support Table4122532021-09-09
00667259003925ELITE SERIE MD-100-With 2 Stirrups Table4122542021-09-09
00667259003932ETNA TABLE (110V) 27 '' 2'' CUSHION WITH HEADREST4127002021-09-09
00667259003949ETNA SBF TABLE (110V) 27'' 2'' CUSHION WITH HEADREST4127162021-09-09
00667259003956ETNA SBF TABLE (110V) 27'' 4'' CUSHION WITH HEADREST4127182021-09-09
00667259003895Soli-Lite LG4 Galileo4115692020-08-17
00667259000030Laguna Mist Flex with Armrest 230V4120044120042017-06-16
00667259000016Laguna Mist 29' 230V4120024120022017-06-16
00667259000443Laguna Mist Flex with Armrest 230V4120044120042017-06-16
00667259000054Laguna Mist 32'' 230V4120144120142017-06-16
00667259003819ELITE SERIE MD-100-With 2 (Stirups & Arm Support) Table4122552019-04-25
00667259003826ELITE SERIE MD-100-With 2 (Stirups & Ergo Armrest) Table4122572019-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.ILY2026-05-02
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347BDRCKED0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347TB202400000TABLED TECHNOLOGIES INCILY2026-04-23
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
00811485037210PMDShenzhen Fittop Health Technology Co., Ltd.ILY2026-01-16
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorBTL INDUSTRIES LIMITEDILY2025-11-19
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
08906172600074LightdoctorLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
08906172600081Theraray LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
00810071230509RegenalaseIPG Medical CorporationILY2025-06-09
00810071230516RegenalaseIPG Medical CorporationILY2025-06-09
00810071230530RegenalaseIPG Medical CorporationILY2025-06-09
16978368600013 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600020 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600037 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05