GENEO, GLO2FACIAL, ELITE 25000510E

GUDID 07290016586671

RF PRO handpiece kit (formerly branded "TriPollar RF Applicator" kit) for GENEO X system (formerly branded "ELITE") in its USA Configuration (also abbreviated 'U').

POLLOGEN LTD

Multi-modality skin contouring system

• Primary Device ID: 07290016586671
• NIH Device Record Key: d3f64b5d-4b9b-431b-ba1b-239b255a9e40
• Commercial Distribution Discontinuation: 2025-02-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GENEO, GLO2FACIAL, ELITE
• Version Model Number: RF PRO handpiece kit for GENEO X system (USA Confi
• Catalog Number: 25000510E
• 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: true
• 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	07290016586671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233766

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: 2025-02-19
• Device Publish Date: 2025-02-11

Devices Manufactured by POLLOGEN LTD

• 07290016586671 - GENEO, GLO2FACIAL, ELITE: 2025-02-19RF PRO handpiece kit (formerly branded "TriPollar RF Applicator" kit) for GENEO X system (formerly branded "ELITE") in its USA Configuration (also abbreviated 'U').
• 07290016586671 - GENEO, GLO2FACIAL, ELITE: 2025-02-19 RF PRO handpiece kit (formerly branded "TriPollar RF Applicator" kit) for GENEO X system (formerly branded "ELITE") in its USA C
• 07290016586459 - Desire model U: 2023-12-25 TRIPOLLAR DESIRE PACKED ROSE GOLD USA
• 07290016586626 - STOP VX2 MODEL U: 2023-12-22
• 17290016586487 - triFX: 2022-06-07 H7X7 DISPOSABLE TIP ASSY 5 PACKED BK
• 07290016586497 - triFX: 2022-06-07 GEN100 DISPOSABLE TIP ASSY 5 PACKED BK
• 07290016586503 - triFX: 2022-06-07 GEN 36L DISPOSABLE TIP ASSY 5 PACKED BK
• 07290016586510 - triFX: 2022-06-07 GEN 36 DISPOSABLE TIP ASSY 5 PACKED BK
• 07290016586527 - triFX: 2022-06-07 GEN 12 DISPOSABLE TIP ASSY 5 PACKED BK