Soli-Lite LG4 Galileo

GUDID 00667259003895

Silhouet-Tone Corporation

Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp

• Primary Device ID: 00667259003895
• NIH Device Record Key: e72e3e2c-955c-433b-93dc-49da17161b6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soli-Lite LG4 Galileo
• Version Model Number: 411569
• Company DUNS: 242049828
• Company Name: Silhouet-Tone Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00667259003895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192755

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-25
• Device Publish Date: 2020-08-17

Devices Manufactured by Silhouet-Tone Corporation

• 00667259003871 - ELITE PLATINUM LINAK (BI-V): 2022-07-27
• 00667259003901 - ELITE SERIE MD-100 W/O Accessories Table: 2021-09-17
• 00667259003918 - ELITE SERIE MD-100-With 2 Arm Support Table: 2021-09-17
• 00667259003925 - ELITE SERIE MD-100-With 2 Stirrups Table: 2021-09-17
• 00667259003932 - ETNA TABLE (110V) 27 '' 2'' CUSHION WITH HEADREST: 2021-09-17
• 00667259003949 - ETNA SBF TABLE (110V) 27'' 2'' CUSHION WITH HEADREST: 2021-09-17
• 00667259003956 - ETNA SBF TABLE (110V) 27'' 4'' CUSHION WITH HEADREST: 2021-09-17
• 00667259003895 - Soli-Lite LG4 Galileo: 2020-08-25
• 00667259003895 - Soli-Lite LG4 Galileo: 2020-08-25