STOP X 34300010RP-US

GUDID 07290018007303

STOP X MODEL STOP U PACKED R.G-CHRM USA

POLLOGEN LTD

Multi-modality skin contouring system

• Primary Device ID: 07290018007303
• NIH Device Record Key: 61f014ea-c1ad-499c-a3f3-c12fce3d4e93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STOP X
• Version Model Number: Model U
• Catalog Number: 34300010RP-US
• Company DUNS: 514905681
• Company Name: POLLOGEN 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018007303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182774

FDA Product Code

• PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

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: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [STOP X]

• 07290018007303: STOP X MODEL STOP U PACKED R.G-CHRM USA
• 07290018007686: STOP X MODEL STOP U PACKED GRADIENT RED USA