AccessGUDID - DEVICE: Sofwave Applicator (07290018152058)

GUDID

Device Identifier (DI) Information

Brand Name: Sofwave Applicator
Version or Model: FG00003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG00003
Company Name: SOFWAVE MEDICAL LTD

Primary DI Number: 07290018152058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531962539 *Terms of Use

Device Description: 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 two forms to allow the user treatment flexibility, This applicator is the small (precise) applicator, designed to allow the user treatment flexibility and easier access to smaller and more curved areas.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62436	Ultrasonic skin contouring system	A mobile assembly of electrically-powered devices intended to temporarily minimize the manifestation of cellulite, loose or wrinkled skin, and/or facial lines through the extracorporeal application of high-intensity/frequency ultrasound [e.g., high intensity focused ultrasound (HIFU)]. It is typically used on the head and neck where it generates low levels of heat in the targeted tissue to stimulate the cells for elastin/collagen production and tissue rejuvenation. It typically consists of a high-intensity/frequency generator/control unit, handpiece, transducer cartridge and connection cable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191421	000
K211483	000
K223237	000
K230019	000
K231537	000
K233104	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea9005d3-4d8e-4d78-a0aa-c5bfe1817ac1
Public Version Date: February 17, 2025
Public Version Number: 2
DI Record Publish Date: April 24, 2023