Sofwave Applicator FG00004

GUDID 07290018152089

The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System consists of two main functional components: 1) the console and 2) the applicator. The applicator component of SofWave System exists in three forms to allow the user treatment flexibility, This applicator is the large (liftHD) applicator, designed to allow the user treatment flexibility and easier access to larger treatment areas.

SOFWAVE MEDICAL LTD

Ultrasonic skin contouring system

• Primary Device ID: 07290018152089
• NIH Device Record Key: c93dd3e9-6efb-4ddc-ae6c-463705aa6f30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sofwave Applicator
• Version Model Number: FG00004
• Catalog Number: FG00004
• Company DUNS: 531962539
• Company Name: SOFWAVE MEDICAL LTD
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018152089 [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: 2025-02-24
• Device Publish Date: 2025-02-16

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
• 07290018152089: The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System c