Opus Plasma Applicator AASP12091714

GUDID 17290110122086

(includes Glide Disposable Tip Set (X12) & Opus Plasma Tip Kit)

ALMA LASERS LTD.

Radio-frequency skin contouring system

• Primary Device ID: 17290110122086
• NIH Device Record Key: 82b179aa-e84e-40dc-b6e4-b06776f7d1c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opus Plasma Applicator
• Version Model Number: 1
• Catalog Number: AASP12091714
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	17290110122086 [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: 2021-02-02
• Device Publish Date: 2021-01-25

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