DENSITY

GUDID 08800020108197

DENSITY Handpiece holder

Jeisys Medical Inc.

Radio-frequency skin/body contouring system

• Primary Device ID: 08800020108197
• NIH Device Record Key: 4e13635a-9330-46d4-aa4f-5612226a196c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENSITY
• Version Model Number: Handpiece holder
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800020108197 [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]

• 08800020108203: DENSITY Handpiece cradle
• 08800020108197: DENSITY Handpiece holder
• 08800020108180: DENSITY Neutral Electrode Pad cable
• 08800020108173: DENSITY Power cord
• 08800020108166: DENSITY_Foot switch