Soli-Lite LG4 Galileo

GUDID 00667259003895

Silhouet-Tone Corporation

Blue/red/infrared phototherapy lamp
Primary Device ID00667259003895
NIH Device Record Keye72e3e2c-955c-433b-93dc-49da17161b6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoli-Lite LG4 Galileo
Version Model Number411569
Company DUNS242049828
Company NameSilhouet-Tone Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100667259003895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-25
Device Publish Date2020-08-17

Devices Manufactured by Silhouet-Tone Corporation

00667259003871 - ELITE PLATINUM LINAK (BI-V)2022-07-27
00667259003901 - ELITE SERIE MD-100 W/O Accessories Table2021-09-17
00667259003918 - ELITE SERIE MD-100-With 2 Arm Support Table2021-09-17
00667259003925 - ELITE SERIE MD-100-With 2 Stirrups Table2021-09-17
00667259003932 - ETNA TABLE (110V) 27 '' 2'' CUSHION WITH HEADREST2021-09-17
00667259003949 - ETNA SBF TABLE (110V) 27'' 2'' CUSHION WITH HEADREST2021-09-17
00667259003956 - ETNA SBF TABLE (110V) 27'' 4'' CUSHION WITH HEADREST2021-09-17
00667259003895 - Soli-Lite LG4 Galileo2020-08-25
00667259003895 - Soli-Lite LG4 Galileo2020-08-25

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