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.

• 08800020106759 - Jeisys Medical Inc.: 2025-09-05 DENSITY Noir Main body
• 08800020106407 - Jeisys Medical Inc.: 2025-09-02 ALPHA Tip
• 18800020105506 - POTENZA Tip: 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-25 Tip)
• 18800020105612 - POTENZA Tip: 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-16 Tip)
• 18800020105629 - POTENZA Tip: 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-49 Tip)
• 18800020106299 - POTENZA Tip: 2025-05-27 POTENZA Tip (DDR Tip)
• 08800020106308 - POTENZA Tip: 2025-05-27 POTENZA Tip (SFA Tip)
• 18800020106312 - POTENZA Tip: 2025-05-27 POTENZA Tip (DIA Tip)