LIPOcel

GUDID 08800020100009

Focused Ultrasound for tissue heat or mechanical cellular disruption

Jeisys Medical Inc.

Ultrasound hyperthermia system transducer, extracorporeal

• Primary Device ID: 08800020100009
• NIH Device Record Key: fe2108be-46b0-4f60-9c9a-db5c9fa9b8cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIPOcel
• Version Model Number: LIPOcel
• Company DUNS: 690275362
• Company Name: Jeisys Medical Inc.
• 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: true
• 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	08800020100009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181896

FDA Product Code

• OHV: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

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: 2020-03-04
• Device Publish Date: 2020-02-25

Devices Manufactured by Jeisys Medical Inc.

• 08800020103536 - DENZA Main body: 2023-09-06 Radio-frequency skin contouring system
• 08800020103918 - DENZA B-Tip II: 2023-09-06 DENZA B-Tip II
• 08800020103925 - DENZA B-Tip: 2023-09-06 DENZA B-Tip
• 08800020103932 - DENZA F-Tip II: 2023-09-06 DENZA F-Tip II
• 08800020103949 - DENZA F-Tip: 2023-09-06 DENZA F-Tip
• 08800020103956 - DENZA I-Tip II: 2023-09-06 DENZA I-Tip II
• 08800020103963 - DENZA I-Tip: 2023-09-06 DENZA I-Tip
• 08800020103970 - DENZA Handpiece: 2023-09-06 Radio-frequency skin contouring system