EXION Face applicator

GUDID B108785APSMUS10

BTL INDUSTRIES LIMITED

Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system

• Primary Device ID: B108785APSMUS10
• NIH Device Record Key: abbab353-7f10-4bfa-a4ac-7453b12d928b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXION Face applicator
• Version Model Number: BTL-785-2
• Company DUNS: 733532951
• Company Name: BTL INDUSTRIES LIMITED
• 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
HIBCC	B108785APSMUS10 [Primary]

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: 2023-05-10
• Device Publish Date: 2023-05-02

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• B108899PO11C1ENUS0140 - EMSCULPT NEO: 2023-12-18
• B108785PO8MUS00 - BTL-785F: 2023-12-11
• B108785PO9MUS00 - BTL-785F: 2023-12-11