Sofwave Applicator FG00002-R

GUDID 07290018152027

SOFWAVE MEDICAL LTD

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• Primary Device ID: 07290018152027
• NIH Device Record Key: 315cc7f4-7021-4f4c-a85a-5a820dd8a2dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sofwave Applicator
• Version Model Number: FG00002-R
• Catalog Number: FG00002-R
• Company DUNS: 531962539
• Company Name: SOFWAVE MEDICAL 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: false
• 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	07290018152027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191421

FDA Product Code

• OHV: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

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: 2021-06-04
• Device Publish Date: 2021-05-27

On-Brand Devices [Sofwave Applicator]

• 07290018152010: FG00002
• 07290018152027: FG00002-R
• 07290018152065: This applicator is the refurbish version of the small (precise) applicator, designed to allow th
• 07290018152058: The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System c