POTENZA

GUDID 08800020111012

Fractional RF Microneedle System

Jeisys Medical Inc.

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system

• Primary Device ID: 08800020111012
• NIH Device Record Key: 5366d69a-a158-49bb-b41c-9c5377c44e55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POTENZA
• Version Model Number: POTENZA
• Company DUNS: 690275362
• Company Name: Jeisys Medical Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800020111012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192545

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2020-03-06
• Device Publish Date: 2020-02-27

Devices Manufactured by Jeisys Medical Inc.

• 08800020103536 - DENZA Main body: 2023-09-06 Radio-frequency skin contouring system
• 08800020103918 - DENZA B-Tip II: 2023-09-06 DENZA B-Tip II
• 08800020103925 - DENZA B-Tip: 2023-09-06 DENZA B-Tip
• 08800020103932 - DENZA F-Tip II: 2023-09-06 DENZA F-Tip II
• 08800020103949 - DENZA F-Tip: 2023-09-06 DENZA F-Tip
• 08800020103956 - DENZA I-Tip II: 2023-09-06 DENZA I-Tip II
• 08800020103963 - DENZA I-Tip: 2023-09-06 DENZA I-Tip
• 08800020103970 - DENZA Handpiece: 2023-09-06 Radio-frequency skin contouring system