EndyMed Pure 85W system 220V

Basic Information

• Brand Name: EndyMed Pure 85W system 220V
• Primary DI: 07290016814293
• Version / Model: Pure 85W system 220V
• Catalog Number: ND_PRD00088-01
• Company Name: ENDYMED MEDICAL LTD
• Labeler DUNS: 531958689
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-03
• Public Version: 3
• Public Version Date: 2023-06-26
• Public Version Status: Update
• Public Device Record Key: e01aa8f7-9574-4a7d-8968-49f8f87086ad
• Distribution End Date: 2023-06-25

Device Description

The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44832	Multi-modality skin contouring system	An assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016814293	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K120513	000