FDA Registration
Active
🇰🇷 South Korea
RF MEDICAL CO., LTD
Reg #: 3015136673
·
FEI: 3015136673
·
Expires 2026
Products
5
Proprietary Names
491
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- RF MEDICAL CO., LTD
- Registration Number
- 3015136673
- FEI Number
- 3015136673
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #502~#507,#511,#601, 254 Beotkkot-ro, Geumcheon-gu
- City
- Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K221277
Owner / Operator
- Firm Name
- RF MEDICAL CO., LTD
- Operator Number
- 10059293
- Address
- #502~#507,#511,#601, 254 Beotkkot-ro, Geumcheon-gu
- City
- Seoul
- State
- KR-11
- Postal Code
- 08513
- Country
- KR
- Correspondent
- Kwang Sun Choi
US Agent
- Business Name
- Mtech Group LLC
- Contact Name
- Dave Kim
- Address
- 7505 Fannin St Ste 610
- City
- Houston
- State
- TX
- ZIP
- 77054
- Country
- US
- [email protected]
- Phone
- 713 4672607
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-09-06 |
| Electrode, Electrosurgical | JOS | Class 2 | General, Plastic Surgery | No | 2023-10-17 |
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2019-06-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-12-11 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2021-09-08 |
Proprietary Names
Mygen M-3004 RF Generator
BIG-TIP (BT 0640PB)
BIG-TIP (BTW 2015B)
BIG-TIP (CWT 1535RB)
MYOBLATE (BTM 3520QB)
MYOBLATE (BTM 3040RB)
JET-TIP® (JET 1510B)
JET-TIP® (JET 1530B)
JET-TIP® (JET 3540XB)
JET-TIP® (JET 2525B)
THYBLATE (RFTP 07XXN)
BIG-TIP (BT 2040B)
BIG-TIP (CWT 3510RB)
BIG-TIP (CWT 1520B)
BIG-TIP (BT 0630B)
BIG-TIP (BTW 1505B)
BIG-TIP (BT 1035B)
BIG-TIP (BTW 1520B)
BIG-TIP (CWT 3520RB)
MYOBLATE (BTM 3515RB)
BIG-TIP (CWT 1520RB)
BIG-TIP (CWT 2040RB)
JET-TIP® (JET 2025XB)
BIG-TIP (BTW 2035B)
JET-TIP® (JET 2530B)
MYOBLATE (BTM 2035QB)
MYOBLATE (BTM 3025QB)
JET-TIP® (JET 2005XB)
JET-TIP® (JET 2020B)
THYBLATE (RFTP 10XXHLN)
JET-TIP® (JET 1505B)
THYBLATE (RFT 10XXL)
THYBLATE (RFTP 07XXHLN)
BIG-TIP (BT 2525B)
BIG-TIP (BT 1035OB)
BIG-TIP (BT 2540B)
BIG-TIP (CWT 2515RB)
MYOBLATE (BTM 2005RB)
JET-TIP® (JET 3030QB)
JET-TIP® (JET 2520QB)
JET-TIP® (JET 2040B)
JET-TIP® (JET 3010QB)
JET-TIP® (JET 2535QB)
JET-TIP® (JET 3025B)
THYBLATE (RFT 10XXHN)
BIG-TIP (BTW 1530B)
BIG-TIP (CWT 3515B)
BIG-TIP (CWT 2015RB)
MYOBLATE (BTM 3515QB)
MYOBLATE (BTM 2540QB)
JET-TIP® (JET 2540XB)
JET-TIP® (JET 2505B)
JET-TIP® (JET 2525QB)
JET-TIP® (JET 2520B)
JET-TIP® (JET 3515QB)
THYBLATE (RFT 07XXHN)
BIG-TIP (BT 0620PB)
BIG-TIP (BT+ 2010B)
BIG-TIP (CWT 3505RB)
BIG-TIP (CWT 2010RB)
MYOBLATE (BTM 3025RB)
JET-TIP® (JET 3520XB)
JET-TIP® (JET 2515B)
JET-TIP® (JET 2035XB)
JET-TIP® (JET 2520XB)
JET-TIP® (JET 2030XB)
JET-TIP® (JET 3030XB)
BIG-TIP (BT 1010B)
BIG-TIP (BT 2035B)
BIG-TIP (CWT 2030B)
BIG-TIP (BT+ 2515B)
MYOBLATE (BTM 3030QB)
MYOBLATE (BTM 2530RB)
JET-TIP® (JET 1535XB)
JET-TIP® (JET 2020XB)
JET-TIP® (JET 3015QB)
JET-TIP® (JET 3005XB)
BIG-TIP (BT 1040OB)
BIG-TIP (CWT 2525RB)
BIG-TIP (CWT 2035RB)
BIG-TIP (CWT 2015B)
BIG-TIP (BT+ 2025B)
MYOBLATE (BTM 3510QB)
JET-TIP® (JET 3525QB)
JET-TIP® (JET 3535XB)
JET-TIP® (JET 2540QB)
JET-TIP® (JET 1530XB)
JET-TIP® (JET 2510B)
THYBLATE (RFT 10XXHLN)
BIG-TIP (BT 2030B)
BIG-TIP (BTW 2030B)
BIG-TIP (CWT 2020B)
BIG-TIP (BT+ 2015B)
MYOBLATE (BTM 2540RB)
JET-TIP® (JET 2505QB)
JET-TIP® (JET 1520QB)
JET-TIP® (JET 2005B)
THYBLATE (RFT 10XXLN)
BIG-TIP (BT 0610B)
BIG-TIP (BT 2005B)
BIG-TIP (CWT 1515RB)
BIG-TIP (CWT 2505RB)
BIG-TIP (BT+ 2040B)
MYOBLATE (BTM 2030QB)
MYOBLATE (BTM 3005RB)
JET-TIP® (JET 1020B)
JET-TIP® (JET 3010XB)
VARY-TIP (VCTU 12XXB)
THYBLATE (RFTP 07XXHN)
BIG-TIP (BT 1540B)
BIG-TIP (BT 0605B)
BIG-TIP (CWT 3540B)
BIG-TIP (CWT 3520B)
MYOBLATE (BTM 2535QB)
MYOBLATE (BTM 3015QB)
JET-TIP® (JET 2010B)
JET-TIP® (JET 1540B)
JET-TIP® (JET 2005QB)
THYBLATE (RFT 07XXH)
BIG-TIP (BT 1005B)
BIG-TIP (BT+ 2035B)
BIG-TIP (BT+ 2030B)
BIG-TIP (BT+ 1535B)
MYOBLATE (BTM 2525QB)
JET-TIP® (JET 2530QB)
JET-TIP® (JET 3540QB)
JET-TIP® (JET 3005QB)
THYBLATE (RFT 10XXHL)
THYBLATE (RFT 07XXL)
BIG-TIP (BT 0625PB)
BIG-TIP (CWT 2020RB)
BIG-TIP (CWT 1525RB)
MYOBLATE (BTM 2525RB)
JET-TIP® (JET 2015QB)
JET-TIP® (JET 1505QB)
JET-TIP® (JET 1040B)
JET-TIP® (JET 3020XB)
JET-TIP® (JET 3015XB)
JET-TIP® (JET 0715TB)
BIG-TIP (BT 2510B)
BIG-TIP (BT 2020B)
BIG-TIP (BT+ 2005B)
BIG-TIP (CWT 2535B)
BIG-TIP (CWT 2025RB)
BIG-TIP (CWT 2025B)
MYOBLATE (BTM 2515QB)
MYOBLATE (BTM 3530QB)
JET-TIP® (JET 1515QB)
JET-TIP® (JET 1540XB)
JET-TIP® (JET 2515QB)
JET-TIP® (JET 2535B)
THYBLATE (RFT 10XX)
THYBLATE (RFTP 10XXHN)
BIG-TIP (BT 0640B)
BIG-TIP (BT 1530B)
BIG-TIP (CWT 1535B)
BIG-TIP (BTW 1510B)
BIG-TIP (CWT 2535RB)
MYOBLATE (BTM 3540RB)
MYOBLATE (BTM 3030RB)
MYOBLATE (BTM 2005QB)
JET-TIP® (JET 3040QB)
JET-TIP® (JET 3505XB)
THYBLATE (RFTP 10XXN)
BIG-TIP (BT 0615PB)
BIG-TIP (BT 1030OB)
BIG-TIP (BT+ 2505B)
BIG-TIP (CWT 2515B)
BIG-TIP (CWT 3525RB)
MYOBLATE (BTM 2015RB)
MYOBLATE (BTM 3020QB)
JET-TIP® (JET 1525QB)
JET-TIP® (JET 1515XB)
JET-TIP® (JET 3025QB)
THYBLATE (RFTP 10XXLN)
BIG-TIP (BT 0635PB)
BIG-TIP (BT 1525B)
BIG-TIP (BT 0610PB)
BIG-TIP (BT+ 1505B)
MYOBLATE (BTM 2505QB)
MYOBLATE (BTM 3035RB)
MYOBLATE (BTM 3535RB)
JET-TIP® (JET 3535QB)
JET-TIP® (JET 2540B)
JET-TIP® (JET 2035B)
JET-TIP® (JET 3525XB)
BIG-TIP (BT 1515B)
BIG-TIP (BTW 1525B)
MYOBLATE (BTM 3525QB)
MYOBLATE (BTM 2025RB)
JET-TIP® (JET 2025B)
JET-TIP® (JET 3040B)
JET-TIP® (JET 3035B)
JET-TIP® (JET 2020QB)
JET-TIP® (JET 3005B)
BIG-TIP (BT 2520B)
BIG-TIP (BT 1005OB)
BIG-TIP (CWT 1525B)
BIG-TIP (CWT 2030RB)
MYOBLATE (BTM 3005QB)
MYOBLATE (BTM 3520RB)
JET-TIP® (JET 1025B)
JET-TIP® (JET 3035XB)
JET-TIP® (JET 1520B)
JET-TIP® (JET 1515B)
BIG-TIP (BT 2025B)
BIG-TIP (CWT 2040B)
BIG-TIP (BT+ 1530B)
BIG-TIP (CWT 3535RB)
BIG-TIP (CWT 2520B)
MYOBLATE (BTM 2010QB)
MYOBLATE (BTM 2530QB)
JET-TIP® (JET 3510XB)
JET-TIP® (JET 3020B)
THYBLATE (RFTPS 07XXLN)
BIG-TIP (BT 1025B)
BIG-TIP (CWT 3510B)
BIG-TIP (CWT 3530RB)
MYOBLATE (BTM 2510RB)
MYOBLATE (BTM 2520RB)
JET-TIP® (JET 3040XB)
JET-TIP® (JET 1035B)
JET-TIP® (JET 3515XB)
JET-TIP® (JET 3530QB)
JET-TIP® (JET 1535B)
BIG-TIP (BT 1015B)
BIG-TIP (BT 1020B)
BIG-TIP (CWT 2010B)
BIG-TIP (BT+ 1525B)
BIG-TIP (CWT 1510B)
MYOBLATE (BTM 2035RB)
MYOBLATE (BTM 3035QB)
JET-TIP® (JET 2010XB)
JET-TIP® (JET 1525XB)
JET-TIP® (JET 2025QB)
JET-TIP® (JET 1505XB)
JET-TIP® (JET 1535QB)
THYBLATE (RFTP 07XXHL)
BIG-TIP (BT 2505B)
BIG-TIP (CWT 2525B)
BIG-TIP (BT+ 2530B)
MYOBLATE (BTM 3530RB)
JET-TIP® (JET 3530XB)
JET-TIP® (JET 0710TB)
JET-TIP® (JET 3025XB)
JET-TIP® (JET 3015B)
VARY-TIP (VCTU 10XXB)
BIG-TIP (BT 1015OB)
BIG-TIP (CWT 2510B)
BIG-TIP (BT+ 2540B)
BIG-TIP (BT+ 2520B)
MYOBLATE (BTM 2030RB)
MYOBLATE (BTM 2535RB)
JET-TIP® (JET 0705TB)
JET-TIP® (JET 2510XB)
JET-TIP® (JET 0735TB)
THYBLATE (RFT 07XXHL)
BIG-TIP (BT 2515B)
BIG-TIP (BT 1510B)
BIG-TIP (CWT 1505B)
BIG-TIP (BT+ 2535B)
BIG-TIP (CWT 2005RB)
BIG-TIP (CWT 1510RB)
BIG-TIP (CWT 2530RB)
MYOBLATE (BTM 2020QB)
MYOBLATE (BTM 3010QB)
JET-TIP® (JET 1015B)
JET-TIP® (JET 1530QB)
JET-TIP® (JET 3505QB)
THYBLATE (RFTP 07XXLN)
THYBLATE (RFT 07XXLN)
BIG-TIP (BT 1040B)
BIG-TIP (BTW 1515B)
BIG-TIP (CWT 2005B)
BIG-TIP (CWT 3505B)
MYOBLATE (BTM 3505RB)
MYOBLATE (BTM 3015RB)
JET-TIP® (JET 0730TB)
JET-TIP® (JET 2030QB)
JET-TIP® (JET 2525XB)
THYBLATE (RFT 07XXHLN)
BIG-TIP (BT 1020OB)
BIG-TIP (BT 1010OB)
BIG-TIP (BTW 2020B)
BIG-TIP (BT+ 1540B)
BIG-TIP (BT+ 2510B)
MYOBLATE (BTM 3540QB)
MYOBLATE (BTM 2040RB)
JET-TIP® (JET 1540QB)
JET-TIP® (JET 2040XB)
THYBLATE (RFT 07XXN)
THYBLATE (RFTS 07XX)
BIG-TIP (BT 0630PB)
BIG-TIP (CWT 3525B)
BIG-TIP (BT+ 1520B)
BIG-TIP (BT+ 1515B)
BIG-TIP (CWT 3535B)
BIG-TIP (CWT 2505B)
BIG-TIP (BT+ 1510B)
MYOBLATE (BTM 3510RB)
JET-TIP® (JET 1510QB)
JET-TIP® (JET 1030B)
THYBLATE (RFTP 10XXHL)
THYBLATE (RFTS 07XXN)
BIG-TIP (BT 2010B)
BIG-TIP (BT 2015B)
BIG-TIP (BTW 2005B)
BIG-TIP (BTW 1535B)
BIG-TIP (CWT 3515RB)
MYOBLATE (BTM 3010RB)
MYOBLATE (BTM 2040QB)
JET-TIP® (JET 2015B)
JET-TIP® (JET 1010B)
JET-TIP® (JET 0725TB)
VARY-TIP (VCTU 20XXB)
BIG-TIP (BT 0615B)
BIG-TIP (CWT 1530RB)
BIG-TIP (CWT 2510RB)
BIG-TIP (CWT 2520RB)
BIG-TIP (CWT 3530B)
MYOBLATE (BTM 3505QB)
JET-TIP® (JET 3520QB)
JET-TIP® (JET 2040QB)
THYBLATE (RFT 10XXH)
THYBLATE (RFT 07XX)
BIG-TIP (BT 2535B)
BIG-TIP (BT 1030B)
BIG-TIP (BT+ 2020B)
BIG-TIP (BTW 2040B)
MYOBLATE (BTM 2510QB)
MYOBLATE (BTM 3525RB)
JET-TIP® (JET 2035QB)
JET-TIP® (JET 2030B)
JET-TIP® (JET 1525B)
THYBLATE (RFTS 07XXLN)
BIG-TIP (BT 1025OB)
BIG-TIP (BT 1535B)
BIG-TIP (BT+ 2525B)
BIG-TIP (BTW 2025B)
BIG-TIP (CWT 1505RB)
MYOBLATE (BTM 3040QB)
MYOBLATE (BTM 2010RB)
JET-TIP® (JET 2515XB)
JET-TIP® (JET 2505XB)
JET-TIP® (JET 1510XB)
THYBLATE (RFTPSP 07XXN)
BIG-TIP (BT 0607PB)
BIG-TIP (BT 0605PB)
BIG-TIP (CWT 1540B)
BIG-TIP (CWT 1530B)
MYOBLATE (BTM 2515RB)
MYOBLATE (BTM 2025QB)
JET-TIP® (JET 3035QB)
JET-TIP® (JET 3030B)
JET-TIP® (JET 1005B)
JET-TIP® (JET 2535XB)
VARY-TIP (VCTU 15XXB)
BIG-TIP (BT 0620B)
BIG-TIP (BT 0625B)
BIG-TIP (CWT 3540RB)
BIG-TIP (CWT 1515B)
BIG-TIP (CWT 2530B)
MYOBLATE (BTM 2015QB)
MYOBLATE (BTM 2505RB)
JET-TIP® (JET 0720TB)
JET-TIP® (JET 3010B)
JET-TIP® (JET 2015XB)
BIG-TIP (BT 2530B)
BIG-TIP (BT 1505B)
BIG-TIP (CWT 2540B)
BIG-TIP (BTW 1540B)
BIG-TIP (BTW 2010B)
BIG-TIP (CWT 2035B)
BIG-TIP (CWT 1540RB)
MYOBLATE (BTM 2020RB)
MYOBLATE (BTM 2520QB)
JET-TIP® (JET 3510QB)
JET-TIP® (JET 2510QB)
THYBLATE (RFT 10XXN)
BIG-TIP (BT 0635B)
BIG-TIP (BT 1520B)
BIG-TIP (CWT 2540RB)
MYOBLATE (BTM 3020RB)
MYOBLATE (BTM 3535QB)
JET-TIP® (JET 0740TB)
JET-TIP® (JET 2530XB)
JET-TIP® (JET 2010QB)
JET-TIP® (JET 3020QB)
JET-TIP® (JET 1520XB)
THYBLATE (RFTS 07XXL)
Mygen V-1000 RF Generator
THYBLATE (RFTSP 07XXN)
THYBLATE (RFTSP 10XXLN)
THYBLATE (RFTSP 07XXLN)
THYBLATE (RFTSP 10XXN)
VertiBlate(BRT 1825B)
MYOBLATE-V(VCT 35XXB)
V-TIP(VCTW 15XXB)
OsteoBlate(BMDT 1310B)
MYOBLATE-V(VCT 30XXB)
V-TIP(VCTW 30XXB)
OsteoBlate(BMDT 1920B)
V-TIP(VCT 30XXB)
THYBLATE-V(RFTVO 10XXV)
VertiBlate(BRT 2115B)
VertiBlate(BRT 1715B)
V-TIP(VCT 15XXB)
OsteoBlate(BMDT 1715B)
OsteoBlate(BMDT 1815B)
VertiBlate(BRT 2010B)
OsteoBlate(BMDT 2010B)
OsteoBlate(BMDT 1910B)
V-TIP(VCT 25XXB)
OsteoBlate(BMDT 1810B)
OsteoBlate(BMDT 2015B)
VertiBlate(BRT 1530B)
OsteoBlate(BMDT 1720B)
V-TIP(VCTW 35XXB)
VertiBlate(BRT 1610B)
THYBLATE-V(RFTVS 10XXV)
THYBLATE-V2(RFTV2 10XXV)
VertiBlate(BRT 1815B)
VertiBlate(BRT 1910B)
THYBLATE-V(RFTV 07XXV)
OsteoBlate(BMDT 1420B)
MYOBLATE-V(VCTM 30XXB)
THYBLATE-V2(RFTVS2 10XXV)
VertiBlate(BRT 1420B)
VertiBlate(BRT 2110B)
OsteoBlate(BMDT 1825B)
THYBLATE-V(RFTVO 07XXV)
OsteoBlate(BMDT 1915B)
VertiBlate(BRT 2015B)
VertiBlate(BRT 1830B)
VertiBlate(BRT 1310B)
MYOBLATE-V(VCT 25XXB)
OsteoBlate(BMDT 2120B)
VertiBlate(BRT 1315B)
OsteoBlate(BMDT 2110B)
THYBLATE-V(RFTVS 07XXV)
V-TIP(VCT 12XXB)
VertiBlate(BRT 1915B)
VertiBlate(BRT 1820B)
OsteoBlate(BMDT 1530B)
V-TIP(VCTW 25XXB)
VertiBlate(BRT 1920B)
VertiBlate(BRT 1720B)
VertiBlate(BRT 2120B)
OsteoBlate(BMDT 2115B)
V-TIP(VCT 35XXB)
OsteoBlate(BMDT 1610B)
VertiBlate(BRT 1810B)
THYBLATE-V2(RFTV2 07XXV)
MYOBLATE-V(VCTM 25XXB)
OsteoBlate(BMDT 1315B)
VertiBlate(BRT 1425B)
V-TIP(VCT 20XXB)
THYBLATE-V(RFTV 10XXV)
OsteoBlate(BMDT 1830B)
OsteoBlate(BMDT 1820B)
V-TIP(VCTW 20XXB)
VertiBlate(BRT 2020B)
V-TIP(VCT 10XXB)
V-TIP(VCTW 10XXB)
OsteoBlate(BMDT 1425B)
MYOBLATE-V(VCTM 35XXB)
THYBLATE-V2(RFTVS2 07XXV)
OsteoBlate(BMDT 2020B)
Electrode Handpieces (BT, JET)
Moving-Shot Guide
Verti-N(VP 1580N)
Verti-N(VP 136186)
Verti-N(VP 1530N)
Verti-N(VP 116166)
Verti-N(VP 1480N)
Verti-N(VP 131191)
Verti-N(VP 126186)
Verti-N(VP 131186)
Verti-N(VP 1430N)
Verti-N(VP 116176)
Verti-N(VP 1180N)
Verti-N(VP 1630N)
Verti-N(VP 136191)
Verti-N(VBI 148199)
Verti-N(VP 1280N)
Verti-N(VP 1330N)
Verti-N(VP 116171)
Verti-N(VP 1380N)
Verti-N(VBI 128179)
Verti-N(VP 141191)
V-Guide
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device