Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PBX · Predicate Candidate Screening
79 FDA 510(k) clearances under this product code; the 50 most recent screened below.
174 daysmedian FDA review time
362 days90th percentile
79clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | 2026-07-10 | 269 | 0 |
| K260647 | SPECCHIO | El.En S.P.A. | 2026-04-02 | 34 | 0 |
| K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-03-13 | 165 | 0 |
| K252888 | NeoSculpt Plus | S&M Medical Co., Ltd. | 2026-03-09 | 180 | 0 |
| K250734 | OptiLUV Device | Pollogen, Ltd. | 2025-09-10 | 183 | 0 |
| K250916 | WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. | 2025-08-14 | 140 | 0 |
| K243716 | Zionic Pro Max (Radiofrequency) | Termosalud S.L. | 2025-05-28 | 177 | 0 |
| K241733 | HEBE (NP0000763) | Novasonix Technology S.L. | 2025-04-16 | 303 | 0 |
| K243055 | Préime DermaFacial Collagen+ | EMA Aesthetics , Ltd. | 2025-04-15 | 200 | 0 |
| K242175 | XOD Diathermia Radiofrequency Device | Xod, Inc. | 2025-02-27 | 218 | 0 |
| K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care | Indiba S. A. U. | 2025-01-24 | 277 | 0 |
| K232966 | FISIOWARM 7.0 | Golden Star Srl | 2024-12-26 | 462 | 0 |
| K242553 | MIRARI® Cold Plasma System ( GV-M2-01) | General Vibronics, Inc. | 2024-11-21 | 86 | 0 |
| K243164 | INDIBA COMPACT devices | Indiba S. A. U. | 2024-11-20 | 51 | 0 |
| K242598 | DEFINE System (AG612444A) | InMode , Ltd. | 2024-11-14 | 76 | 0 |
| K240991 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-09 | 181 | 0 |
| K240178 | RFG-01 | Zimmer Medizinsysteme GmbH | 2024-07-15 | 174 | 0 |
| K230755 | NuEra Tight RF Model OptiStream | Bios S.R.L. | 2023-10-30 | 227 | 0 |
| K230037 | BACK 3 | Swims America Corp | 2023-07-19 | 194 | 0 |
| K230659 | Zionic Aesthetic | Termosalud | 2023-06-08 | 91 | 0 |
| K213256 | ThermoTK | Zimmer Medizinsysteme GmbH | 2023-05-25 | 602 | 0 |
| K223907 | NuEra Tight RF Model APMD145.M70-US | Bios S.R.L. | 2023-05-02 | 125 | 0 |
| K230412 | Symmed Elite Aesthetic | Termosalud | 2023-04-13 | 57 | 0 |
| K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300 | Capenergy Medical S.L. | 2023-03-28 | 243 | 0 |
| K220014 | RSHOCK | Swims America Corp | 2023-03-01 | 420 | 0 |
| K221043 | Doctor Tecar Plus, Doctor Tecar Smart | Mectronic Medicale S.R.L. | 2023-02-17 | 315 | 0 |
| K213295 | C.C. LIFE 21 | 21 Equipment S.R.L. | 2022-11-17 | 412 | 0 |
| K214090 | Back 3 COLOR | Swims America Corp | 2022-11-01 | 308 | 0 |
| K214015 | Palm NRG cellulite body device (model: Palm NRG body device) | Heat IN A Click, LLC | 2022-09-26 | 278 | 0 |
| K212253 | Apollo Duet (Model : APD-4000) | Weero Co. | 2022-08-25 | 402 | 0 |
| K211207 | Diacare 7000 | Globus Sport and Health Technologies, LLC | 2022-06-06 | 410 | 0 |
| K220592 | Venus BlissMAX | Venus Concept USA, Inc. | 2022-04-27 | 57 | 0 |
| K213308 | Venus BlissMAX | Venus Concept USA, Inc. | 2022-01-12 | 100 | 0 |
| K211091 | Deka Tiac II | El.En Electronic Engineering Spa | 2021-10-15 | 186 | 0 |
| K211461 | Family of Venus RF Systems - Venus Freedom | Venus Concept USA, Inc. | 2021-10-14 | 156 | 0 |
| K202780 | Sectum | Neauvia North America | 2021-07-30 | 311 | 0 |
| K210129 | RF Thermal System | Luvo Medical Technologies, Inc. | 2021-07-20 | 182 | 0 |
| K210877 | Evolve System with the T3 Applicator | InMode , Ltd. | 2021-07-19 | 117 | 0 |
| K210867 | NuEra Tight RF, NuEra Tight RF Plus | Bios S.R.L. | 2021-04-21 | 29 | 0 |
| K202247 | V30 system, V20 system, V10 system, V-VR Hand piece | Viora , Ltd. | 2020-12-09 | 121 | 0 |
| K191940 | Palm NRG cellulite and muscle toning body device | Heat IN A Click | 2020-11-03 | 473 | 0 |
| K201475 | Ultimate Contour, Ultimate Contour Mini | CAO Group, Inc. | 2020-10-28 | 147 | 0 |
| K200359 | NuEra Tight, NuEra Tight EMS | Bios S.R.L. | 2020-08-11 | 180 | 0 |
| K201064 | V30 System, V20 System, V10 System, V-FR Handpiece | Viora , Ltd. | 2020-07-15 | 85 | 0 |
| K200468 | V30 system, V20 system, V10 system, V-FC Handpiece | Viora , Ltd. | 2020-05-21 | 85 | 0 |
| K200241 | TempSure System | Cynosure, LLC | 2020-03-25 | 54 | 0 |
| K191202 | CAPENERGY - C100, C200, C300, C400, C50 | Capenergy Medical S.L. | 2020-02-11 | 281 | 0 |
| K183371 | Deka Tiac 1 | El..En. Electroic Engineering Spa | 2019-12-03 | 362 | 0 |
| K191855 | EmFace Device | Inmode MD , Ltd. | 2019-10-29 | 111 | 0 |
| K190743 | Venus Bliss | Venus Concept USA, Inc. | 2019-06-25 | 95 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda