VOLNEWMER I tip

GUDID 08800016905397

CLASSYS Inc.

Radio-frequency skin contouring system applicator tip

• Primary Device ID: 08800016905397
• NIH Device Record Key: cdce7128-e2eb-4047-8b2a-b0a20beaabc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOLNEWMER I tip
• Version Model Number: VLMC02502R
• Company DUNS: 689842183
• Company Name: CLASSYS 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	08800016905397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240248

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: 2025-06-24
• Device Publish Date: 2025-06-16

On-Brand Devices [VOLNEWMER I tip]

• 08800016902730: VLMC02501
• 08800016905397: VLMC02502R