Opus System 110V AASP12091701BA0001

GUDID 17290110121782

ALMA LASERS LTD.

Multi-modality skin surface treatment system

• Primary Device ID: 17290110121782
• NIH Device Record Key: d4f97844-a114-493d-a227-8ca7811ed833
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opus System 110V
• Version Model Number: 1
• Catalog Number: AASP12091701BA0001
• 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	17290110121782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101147

FDA Product Code

• IMI: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

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: 2020-02-28
• Device Publish Date: 2020-02-20

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