TS-RF Generator (STS10)
Starmed Co., Ltd.
STARMED CO.,LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013557681 | 3013557681 | STARMED CO.,LTD | 1 | N | 2026-01-01 | (Jungsan-dong, Daebang-Triplaon Business Tower),B-dong, 4F&12F, 158, Haneulmaeul-ro Ilsandong-gu, Goyang-si Gyeonggi KR 10355 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 206017 | 1515812342 | K252833 | |||
| 206017 | 1475081467 | K251566 | TS-RF Generator (STS10) | GEI | 2025-11-17 |
| 206017 | 1806530042 | K234140 | VIVA combo RF System (VIVA combo RF System) | GEI | 2024-01-30 |
| 206017 | 1356956661 | K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | KNS | 2023-10-25 |
| 206017 | 2037190095 | K222997 | VVR Generator system | GEI | 2023-10-25 |
| 206017 | 1233399344 | K203795 | Star RF Electrode, VIVA RF Electrode | GEI | 2021-04-01 |
| 206017 | 1151112400 | K183538 | VIVA combo RF System | GEI | 2019-01-17 |
| 206017 | 1857236764 | K181758 | ELRA Electrode | KNS | 2019-04-11 |
| 206017 | 1536142320 | K181249 | EUSRA RF Electrode | GEI | 2018-09-04 |
| 206017 | 1233383175 | K172012 | star RF Electrode, VIVA RF Electrode | GEI | 2018-03-14 |
| 206017 | 1540468815 | K163450 | VIVA combo RF System | GEI | 2017-03-08 |
Product Codes Associated With Registrations#
PMN#
VIVA combo RF System (VIVA combo RF System)
Starmed Co., Ltd.
ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
Starmed Co., Ltd.
VVR Generator system
Starmed Co., Ltd.
Star RF Electrode, VIVA RF Electrode
STARmed Co., Ltd.
ELRA Electrode
STARmed Co., Ltd.
VIVA Combo RF System
STARmed Co., Ltd.
EUSRA RF Electrode
STARmed Co., Ltd.
Star RF Electrode, VIVA RF Electrode
STARmed Co., Ltd.
VIVA Combo RF System
STARmed Co., Ltd.
GUDID#
TS-RF Generator - The TS-RF Generator consists of an RF generator, cables, and components. This TS-RF Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue. Radiofrequency power is supplied and controlled with a maximum of 50 watts. Data Logs can be stored by connecting the USB Flash Driver with the communication terminal of the rear panel of the RF generator.
2025-12-01
VVR Generator - VVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and cooling pump. The generator generates, controls and monitors RF energy and delivers energy to the active electrode. The active electrode has an active coil and a receiver coil that allow the RF energy to flow through the tissue. The RF energy raises the temperature in the tissue, causing coagulation and occlusion of blood vessels. The single footswitch works as an on/off switch and the double footswitch works to increase or decrease the power output. A cooling pump circulates water around the electrodes to reduce the temperature of the electrodes and prevent tissue sticking to the electrodes.
2024-09-30
VENISTAR - 7-VENI007090N
2024-08-29
VENISTAR - 3-VENI003090N
2024-08-29
VENISTAR - 3-VENI0030N
2024-08-29
VENISTAR - 7-VENI0070N
2024-08-29
VENISTAR - 7-VENI007090N
2024-08-29
VENISTAR - 3-VENI003090N
2024-08-29
VENISTAR - 3-VENI0030N
2024-08-29
VENISTAR - 7-VENI0070N
2024-08-29
ELRA Electrode - 7-2B11L
2024-08-28
ELRA Electrode - 7-2B11L
2024-08-28
ELRA Electrode - 7-2B11S
2023-11-24
ELRA Electrode - 7-2B22S
2023-11-24
ELRA Electrode - 7-2B22L
2023-11-24
ELRA Electrode - 7-4B18S
2023-11-24
ELRA Electrode - 7-4B18L
2023-11-24
ELRA Electrode - 7-4B33S
2023-11-24
ELRA Electrode - 7-4B33L
2023-11-24
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2018-03-21
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handleand tubing.
2017-05-19
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handleand tubing.
2018-03-21
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2018-03-21
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2018-03-21
VIVA RF Electrode - The VIVA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
VIVA RF Electrode - The VIVA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2018-03-21
VIVA RF Electrode - The VIVA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2018-03-21
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handleand tubing.
2017-05-19
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2021-04-09
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2018-03-21
star RF Electrode - The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.
2018-03-21