| Primary Device ID | 07290016586121 |
| NIH Device Record Key | e4947767-ed1c-43fd-a5e5-6164657d3bfa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TriFractional (TF) disposable tips |
| Version Model Number | H7X7 |
| Catalog Number | 30010140 |
| Company DUNS | 514905681 |
| Company Name | POLLOGEN LTD |
| Device Count | 5 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016586121 [Primary] |
| GS1 | 17290016586128 [Unit of Use] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-20 |
| Device Publish Date | 2019-05-12 |
| 07290016586565 - Applicator 3 | 2026-02-10 |
| 07290016586572 - Applicator VO | 2026-02-10 |
| 07290016586763 - triLift FACE | 2026-02-10 The device is a software-controlled capital equipment platform that enables application of radiofrequency (RF) energy onto the s |
| 07290016586770 - Applicator 1 | 2026-02-10 |
| 07290016586787 - Applicator 2 | 2026-02-10 |
| 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 |