VOLNEWMER I tip(D)

GUDID 08800016905434

CLASSYS Inc.

Radio-frequency skin contouring system applicator tip

• Primary Device ID: 08800016905434
• NIH Device Record Key: c75fd3aa-1d49-4684-926e-6ebcf0a4ea5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOLNEWMER I tip(D)
• Version Model Number: VLMC02502D
• 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	08800016905434 [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

Devices Manufactured by CLASSYS Inc.

• 08800016905366 - VOLNEWMER S tip: 2025-06-24
• 08800016905373 - VOLNEWMER V tip: 2025-06-24
• 08800016905380 - VOLNEWMER F tip: 2025-06-24
• 08800016905397 - VOLNEWMER I tip: 2025-06-24
• 08800016905403 - VOLNEWMER S tip(D): 2025-06-24
• 08800016905410 - VOLNEWMER V tip(D): 2025-06-24
• 08800016905427 - VOLNEWMER F tip(D): 2025-06-24
• 08800016905434 - VOLNEWMER I tip(D): 2025-06-24
• 08800016905434 - VOLNEWMER I tip(D): 2025-06-24