510(k) K242553
- Device
- MIRARI® Cold Plasma System ( GV-M2-01)
- Applicant
- General Vibronics, Inc.
- 510(k) number
- K242553
- Product code
- PBX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-21
- Date received
- 2024-08-27
- Regulation
- 878.4400
- Classification name
- Massager, Vacuum, Radio Frequency Induced Heat
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Huan Truong
- Address
- 1615 E. Warner Rd. Suite #4 Tempe AZ US 85284 85284
FDA Registration Numbers
- 3043140693
- 3007491751
- 3038715747
- 3015283772
- 3016496662
- 1222993
- 3009736547
- 3018994966
- 3010511300
- 3008729892
- 3007544634
- 3038280308
- 3013517192
- 3011307265
- 9612147
- 3016446653
- 3006807694
- 3010402752
- 3015433394
- 3016746323
- 3015452693
- 3008085016
- 3013602304
- 3016413636
- 3035374386
- 3007712511
- 3011670002
- 3030230686
- 3043657394
- 3002808227
- 3016087653
- 3013734919
- 3011070163
- 3026400760
- 3007421149
- 3006850277
- 3016512343
- 8010720
- 2087572
- 3013652305
- 3001431138
- 3004940677
- 2954354
- 3005695724
- 3023339107
- 3006515340
- 8040510
- 3015779311
- 3011782009
- 3004784537
- 3008915316
- 3006153348
- 3008929787
- 3022747124
- 9680721
- 3017263740
- 3021177911
- 3013917867
- 3013539104
- 3010363436
- 3030420005
- 3017954802
- 3010836847
- 3016675013
- 1725006
- 8040537
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860013508647 | Insulating Waterproof ePTFE Pouch | General Vibronics, LLC | 2025-04-30 |
| 00860013508630 | MIRARI Cold Plasma System Array | General Vibronics, LLC | 2025-04-30 |
| 00860013508623 | MIRARI Cold Plasma System Insulating Fleece Pouch | General Vibronics, LLC | 2025-04-30 |
| 00860013508616 | MIRARI Cold Plasma Driver | General Vibronics, LLC | 2025-04-30 |
| 00860013508609 | MIRARI Cold Plasma unit box set | General Vibronics, LLC | 2025-04-30 |
Other 510(k) Records For Product Code PBX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260647 | SPECCHIO | El.En S.P.A. | 2026-04-02 |
| K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-03-13 |
| K252888 | NeoSculpt Plus | S&M Medical Co., Ltd. | 2026-03-09 |
| K250734 | OptiLUV Device | Pollogen, Ltd. | 2025-09-10 |
| K250916 | WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. | 2025-08-14 |
| K243716 | Zionic Pro Max (Radiofrequency) | Termosalud S.L. | 2025-05-28 |
| K241733 | HEBE (NP0000763) | Novasonix Technology S.L. | 2025-04-16 |
| K243055 | Préime DermaFacial Collagen+ | EMA Aesthetics , Ltd. | 2025-04-15 |
| K242175 | XOD Diathermia Radiofrequency Device | Xod, Inc. | 2025-02-27 |
| K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) | Indiba S. A. U. | 2025-01-24 |
| K232966 | FISIOWARM 7.0 | Golden Star Srl | 2024-12-26 |
| K243164 | INDIBA COMPACT devices | Indiba S. A. U. | 2024-11-20 |
| K242598 | DEFINE System (AG612444A) | InMode , Ltd. | 2024-11-14 |
| K240991 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-09 |
| K240178 | RFG-01 | Zimmer Medizinsysteme GmbH | 2024-07-15 |