Bipolar HP AASR11021401

GUDID 17290110121607

ALMA LASERS LTD.

Radio-frequency skin contouring system

• Primary Device ID: 17290110121607
• NIH Device Record Key: 7b68fd87-a5d9-4435-b209-fe89437b866a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar HP
• Version Model Number: 1
• Catalog Number: AASR11021401
• Company DUNS: 532283264
• Company Name: ALMA LASERS LTD.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290110121607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160075

FDA Product Code

• NUV: Massager, Vacuum, Light Induced Heating

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: 2018-09-24
• Device Publish Date: 2018-08-22

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