Opus Plasma HP/Applicator AASP12091710

GUDID 17290110121805

ALMA LASERS LTD.

Radio-frequency skin contouring system

• Primary Device ID: 17290110121805
• NIH Device Record Key: becc4f4c-72b2-4d84-ac4e-273d5e33e0a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opus Plasma HP/Applicator
• Version Model Number: 01
• Catalog Number: AASP12091710
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290110121805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101147

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: 2020-02-25
• Device Publish Date: 2020-02-17

Devices Manufactured by ALMA LASERS LTD.

• 17290110123526 - Diode 755nm Alex Applicator for Soprano Titanium (Black): 2024-03-25 Diode 755nm Alex Applicator for Soprano Titanium (Black)
• 07290110123451 - ClearVas: 2024-02-26
• 07290110123468 - ClearLift: 2024-02-26
• 07290110123475 - Alma SupErb: 2024-02-26
• 07290110123482 - ClearSkin: 2024-02-26
• 07290110123444 - NIR Face (6) HP: 2024-02-07
• 07290110123406 - Iris SR IPL HP: 2024-02-06
• 07290110123413 - Iris VL/PL IPL HP: 2024-02-06