510(k) submissions
Filtered by Other · showing 1–36 of 36
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K260522 | RhinAer+ StylusSurgery | Aerin Medical, Inc.United States | RF Ablation | Class 2 | 2026-05-18 |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)Surgery | Zhejiang shuyou Surgical Instrument Co., Ltd.China | RF Ablation | Class 2 | 2026-04-07 |
| K253750 | BTL-785NEHPain Management | BTL Industries, Inc.United States | RF Generator | Class 2 | 2026-03-17 |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Surgery | Gyrus Acmi, Inc.United States | RF Ablation | Class 2 | 2026-03-02 |
| K251813 | CURIS II RF Generator (REF 360100-05)Surgery | Sutter Medizintechnik GmbHGermany | RF Generator | Class 2 | 2026-02-11 |
| K251836 | Dermatrix DuoPain Management | Shenzhen Gsd Technology Co., Ltd.China | RF Ablation | Class 2 | 2026-02-06 |
| K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Surgery | Shenzhen Peninsula Medical GroupChina | RF Generator | Class 2 | 2026-01-30 |
| K251435 | InbellaIgnite RF SystemSurgery | Inbella Medical, Inc.Canada | RF Ablation | Class 2 | 2026-01-27 |
| K251254 | Ignite RF SystemSurgery | InMode , Ltd.Israel | RF Ablation | Class 2 | 2026-01-15 |
| K251988 | Boston iFace (Boston iFace)Pain Management | Boston Aesthetics, Inc.United States | RF Ablation | Class 2 | 2026-01-12 |
| K250852 | CoolfaseSurgery | Asterasys Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-10-16 |
| K252367 | InbellaMulti SystemPain Management | Inbella Medical, Inc.Canada | RF Ablation | Class 2 | 2025-10-15 |
| K250688 | Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)Surgery | Acotec Scientific Co., Ltd.China | RF Ablation | Class 2 | 2025-10-07 |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)Surgery | Olympus Winter & Ibe GmbHUnited States | RF Ablation | Class 2 | 2025-09-23 |
| K250217 | AGNES UltraSurgery | Agnes Medical Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-09-03 |
| K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Surgery | Venclose, Inc.United States | RF Generator | Class 2 | 2025-08-19 |
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)Surgery | Agnes Medical Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-08-19 |
| K252083 | HOTWIRE™ System RF Generator and Footswitch (optional accessory)Surgery | Atraverse Medical, Inc.United States | RF Generator | Class 2 | 2025-08-12 |
| K252211 | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)Surgery | Cnc TechnologiesKorea, Republic of | RF Generator | Class 2 | 2025-08-11 |
| K251327 | XERFSurgery | Lutronic CorporationKorea, Republic of | RF Ablation | Class 2 | 2025-08-11 |
| K252215 | InbellaMAX SystemOther | Inbella Medical, Inc.Canada | Energy Device | Class 2 | 2025-07-25 |
| K250065 | DENSITY; DENZA; DENSITY NoirSurgery | Jeisys Medical IncorporatedKorea, Republic of | RF Ablation | Class 2 | 2025-07-08 |
| K243120 | HybridAPC probeSurgery | Erbe Elektromedizin GmbHUnited States | RF Ablation | Class 2 | 2025-06-20 |
| K251235 | Electrosurgical PadsSurgery | Baisheng Medical Co., Ltd.China | RF Ablation | Class 2 | 2025-06-19 |
| K242996 | EndyMed PRO MAXPain Management | Endymed Medical, Ltd.Israel | RF Ablation | Class 2 | 2025-06-10 |
| K250657 | gi2000 Electrosurgical GeneratorSurgery | Cintron Medical CorporationUnited States | RF Generator | Class 2 | 2025-06-03 |
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)Surgery | Maquet Cardiovascular, LLCUnited States | Endoscopic Instrument | Class 2 | 2025-05-30 |
| K242469 | RFMagik LiteSurgery | Agnes Medical Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-04-25 |
| K242241 | SunnyPain Management | ShenB Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-03-19 |
| K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)Surgery | Boston Aesthetics, Inc.United States | RF Generator | Class 2 | 2025-02-13 |
| K250200 | InbellaBody SystemPain Management | Inbella Medical, Inc.Canada | RF Ablation | Class 2 | 2025-02-11 |
| K250068 | Venclose digiRF Generator (VCRFG1)Surgery | Venclose, Inc.United States | RF Generator | Class 2 | 2025-02-04 |
| K243139 | Reverso Pro SystemSurgery | Indiba S. A. U.Spain | RF Ablation | Class 2 | 2025-01-22 |
| K243929 | Oligio XSurgery | Wontech Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-01-21 |
| K243737 | Inbella RF SystemSurgery | Inbella Medical, Inc.Canada | RF Ablation | Class 2 | 2025-01-03 |
| K233118 | DUET-V (Model: ESK-3261DV)Surgery | Eunsung Global CorpKorea, Republic of | RF Ablation | Class 2 | 2025-01-03 |