Accent Prime Ultra Applicator for Inc. AAAP07042215

GUDID 07290110122348

The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

ALMA LASERS LTD.

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• Primary Device ID: 07290110122348
• NIH Device Record Key: 8c6fc4a9-fe07-487e-9e74-f00123421b38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accent Prime Ultra Applicator for Inc.
• Version Model Number: 1
• Catalog Number: AAAP07042215
• 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: true
• 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	07290110122348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160075

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: 2022-11-30
• Device Publish Date: 2022-11-22

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