DENSITY Tip

GUDID 08800020108289

DENSITY Tip_Classic-B Tip

Jeisys Medical Inc.

Radio-frequency skin/body contouring system

• Primary Device ID: 08800020108289
• NIH Device Record Key: 5a71d3dd-399a-48f8-bc83-f4f6d6b73a37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENSITY Tip
• Version Model Number: Classic-B Tip
• 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: true
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800020108289 [Package]; Contains: 08800020108333; Package: Paper box [6 Units]; In Commercial Distribution
GS1	08800020108333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250065

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2026-03-24
• Device Publish Date: 2026-03-16

On-Brand Devices [DENSITY Tip]

• 08800020108326: DENSITY Tip_High-F Tip
• 08800020108319: DENSITY Tip_High-E Tip
• 08800020108302: High-B Tip
• 08800020108296: DENSITY Tip_Classic-F Tip
• 08800020108272: DENSITY Tip_Classic-E Tip
• 08800020108289: DENSITY Tip_Classic-B Tip