BTL Exilite handpiece

GUDID B108216APIPLF1140ENUS0

BTL INDUSTRIES LIMITED

Multi-modality skin surface treatment system

• Primary Device ID: B108216APIPLF1140ENUS0
• NIH Device Record Key: f7d17fc3-00c0-4d7e-a578-356a9c08dd05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BTL Exilite handpiece
• Version Model Number: BTL Exilite handpiece
• 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	B108216APIPLF1140ENUS0 [Primary]

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-12

On-Brand Devices [BTL Exilite handpiece]

• B108216APIPLF1140US1020: BTL Exilite handpiece
• B108216APIPLF1140US0: BTL Exilite handpiece
• B108216APIPLF1140ENUS0: BTL Exilite handpiece