510(k) submissions
Filtered by Pain Management · showing 1–22 of 22
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K252833 | VIVA combo RF SystemSurgery | Starmed Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2026-05-26 |
| K254122 | FLOW FLEXTEND Wand (72290039)Surgery | ArthroCare CorporationUnited States | RF Ablation | Class 2 | 2026-03-30 |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)Surgery | Aventix Medical, Inc.United States | RF Ablation | Class 2 | 2026-03-27 |
| K253750 | BTL-785NEHPain Management | BTL Industries, Inc.United States | RF Generator | Class 2 | 2026-03-17 |
| 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 |
| K251988 | Boston iFace (Boston iFace)Pain Management | Boston Aesthetics, Inc.United States | RF Ablation | Class 2 | 2026-01-12 |
| K252367 | InbellaMulti SystemPain Management | Inbella Medical, Inc.Canada | RF Ablation | Class 2 | 2025-10-15 |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)Surgery | Olympus Medical Systems CorporationJapan | Energy Device | Class 2 | 2025-10-07 |
| K251899 | E BlatorSurgery | New Deantronics Taiwan , Ltd.Taiwan | RF Ablation | Class 2 | 2025-10-01 |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke EvacuationSurgery | Stryker InstrumentsUnited States | RF Ablation | Class 2 | 2025-09-09 |
| K243120 | HybridAPC probeSurgery | Erbe Elektromedizin GmbHUnited States | RF Ablation | Class 2 | 2025-06-20 |
| K242996 | EndyMed PRO MAXPain Management | Endymed Medical, Ltd.Israel | RF Ablation | Class 2 | 2025-06-10 |
| K250048 | NEUROMARK System (NMK00301)Surgery | Neurent Medical , Ltd.Ireland | RF Ablation | Class 2 | 2025-05-29 |
| K250327 | OptaBlate Radiofrequency (RF) Generator SystemPain Management | Stryker InstrumentsUnited States | RF Generator | Class 2 | 2025-04-15 |
| K242241 | SunnyPain Management | ShenB Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-03-19 |
| K243918 | Vasoview Hemopro 3 Power SupplySurgery | Maquet Cardiovascular, LLCUnited States | RF Generator | Class 2 | 2025-02-26 |
| 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 |
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050)Surgery | Creo Medical, Ltd.United Kingdom | RF Generator | Class 2 | 2025-02-05 |
| K243139 | Reverso Pro SystemSurgery | Indiba S. A. U.Spain | RF Ablation | Class 2 | 2025-01-22 |