FDA.reportPublic FDA data

Soli-Lite LG4 Galileo

Primary DI
00667259003895
Brand
Soli-Lite LG4 Galileo
Company
Silhouet-Tone Corporation
Model
411569
Published
2020-08-17
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
GEXPowered Laser Surgical Instrument
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192755000Soli-Lite LG4 GalileoSilhouet-Tone Corporation2019-12-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00667259003895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00667259003895006672590038956672590038950667259003895

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
242049828
Device count
1
Serial number
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
00667259001952Soli-Lite LG2 Spectra4115602018-08-24
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
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
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00816073022623Wabbo Infrared LampHealth Body World Supply Inc.ILY2023-10-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
00816073022654XinFeng Heat LampHealth Body World Supply Inc.ILY2019-07-12
00816073022647XinFeng Heat LampHealth Body World Supply Inc.ILY2019-07-11
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08057017760382DEKA SmartXide² TRIO C60HEL.EN. SPAGEX2018-11-26
08057017760399DEKA SmartXide² TRIO C80HEL.EN. SPAGEX2018-11-26
08033945938413Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938420Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28