EndyMed PRO MAX, Small MAX Handpiece ND_PRD00470-00

GUDID 07290016814422

The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.

ENDYMED MEDICAL LTD

Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system

• Primary Device ID: 07290016814422
• NIH Device Record Key: 5c4b3edc-8184-4ff7-8cdc-a744a1a32fa9
• Commercial Distribution Discontinuation: 2024-05-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EndyMed PRO MAX, Small MAX Handpiece
• Version Model Number: Small MAX Handpiece
• Catalog Number: ND_PRD00470-00
• Company DUNS: 531958689
• Company Name: ENDYMED 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016814422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083461

FDA Product Code

• OUH: Skin Resurfacing Rf Applicator

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: 2024-05-24
• Device Publish Date: 2024-05-16

Devices Manufactured by ENDYMED MEDICAL LTD

• 07290016814408 - EndyMed PRO MAX, System, 110V: 2024-05-24 The EndyMed PRO MAX System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non-
• 07290016814415 - endyMed PRO MAX, Intensif MAX Handpiece: 2024-05-24 The Intensif applicator is intended for use in dermatologic and general surgical procedure for electrocoagulation nd hemostasis
• 07290016814422 - EndyMed PRO MAX, Small MAX Handpiece: 2024-05-24The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
• 07290016814422 - EndyMed PRO MAX, Small MAX Handpiece: 2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
• 07290016814439 - EndyMed PRO MAX, FSR MAX Handpiece: 2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
• 07290016814446 - EndyMed PRO MAX, iFine MAX Handpiece: 2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
• 07290016814453 - EndyMed PRO MAX,Shaper MAX Handpiece: 2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
• 07290016814460 - EndyMed PRO MAX,Mini Shaper MAX Handpiece: 2024-05-24 The handpiece is used as an accessory to EndyMed PRO MAX system, which is a noninvasive device intended for use in Dermatologi
• 07290016814477 - EndyMed PRO MAX, Contour MAX Handpiece: 2024-05-24 The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator fo