Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 36
- Latest Decision
- 2023-04-07
Clearances · page 14 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K223373 | Enivo | Aroa Biosurgery , Ltd. | BTA | Class II | 2023-04-07 |
| DEN210055 | The N-SWEAT Patch | Candesant Biomedical, Inc. | QVX | Class II | 2023-04-07 |
| K223052 | Peri-Guard and Supple Peri-Guard | Synovis Life Technologies, Inc. | FTM | Class II | 2023-04-07 |
| K230097 | IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 | Shenzhen Bsx Technology Electronics Co., Ltd. | OHT | Class II | 2023-04-06 |
| K230107 | Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 | Kam Yuen Plastic Products , Ltd. | OHT | Class II | 2023-04-05 |
| K222012 | FAQ 101 | Foreo, Inc. | PAY | Class II | 2023-04-05 |
| K230021 | IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 | Shenzhen Yangyi Technology ., Ltd. | OHT | Class II | 2023-03-31 |
| K230274 | Medical Diode Laser (M2) | Wuhan Pioon Technology Co., Ltd. | GEX | Class II | 2023-03-31 |
| K223778 | Diode Laser Hair Removal System (RD-SLD600) | Shanghai Omni Laser Skinology Co., Ltd. | GEX | Class II | 2023-03-31 |
| K222485 | SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser | Ids, Limited | GEX | Class II | 2023-03-29 |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | Stryker Sustainability Solutions | NUJ | Class II | 2023-03-28 |
| K223625 | CapnoSpot Pneumothorax Decompression Indicator | Pneumeric, Inc. | GAA | Class I | 2023-03-28 |
| K230271 | ISOLIS Cryoprobe | Varian Medical Systems, Inc. | GEH | Class II | 2023-03-28 |
| K223928 | Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K | Shenzhen Fansizhe Science and Technology Co., Ltd. | OHT | Class II | 2023-03-28 |
| K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | Capenergy Medical S.L. | PBX | Class II | 2023-03-28 |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 | Stryker Sustainability Solutions | GEI | Class II | 2023-03-28 |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | NEY | Class II | 2023-03-27 |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | FTC | Class II | 2023-03-27 |
| K223823 | Disposable Surgical Face Mask | Efofex, Inc. | FXX | Class II | 2023-03-27 |
| K223236 | Medline Surgical Face Mask and Medline Procedural Face Mask | Medline Industries, LP | FXX | Class II | 2023-03-24 |
| K230382 | 3 Series NeoLux | Daavlin Distributing Co. | FTC | Class II | 2023-03-24 |
| K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | KPJ | Class II | 2023-03-23 |
| K221585 | 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit | 3M Healthcare Business Group | OMP | Class II | 2023-03-23 |
| K222859 | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) | 3M | OMP | Class II | 2023-03-23 |
| K223488 | ClosureFast Endovenous Radiofrequency Ablation Catheter | Medtronic, Inc. | GEI | Class II | 2023-03-23 |
| K222620 | Sterilized Latex Surgical Gloves | Suzhou Colour-Way New Material Co., Ltd. | KGO | Class I | 2023-03-23 |
| K230194 | HF Surgery Generator 400KHZ | Richard Wolf Medical Instruments Corporation | GEI | Class II | 2023-03-22 |
| K222617 | EasyTouch Lancing Device | Stat Medical Devices | QRK | Class II | 2023-03-21 |
| K214070 | OviTex PRS (Long Term Resorbable) | Tela Bio | FTM | Class II | 2023-03-21 |
| K222709 | Retraction, CWM-910T, APOLEX Tite | Chungwoo Co., Ltd. | GEI | Class II | 2023-03-21 |
| K220725 | HPR45i | F Care Systems USA, LLC | GEI | Class II | 2023-03-20 |
| K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) | Light Tree Ventures Europe B.V. | OHS | Class II | 2023-03-15 |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G) | Ethicon Endo-Surgery | GDW | Class II | 2023-03-15 |
| K222983 | NeuroBlate Fusion-S Software V3.17 | Monteris Medical, | GEX | Class II | 2023-03-15 |
| K230019 | SofWave System | Sofwave Medical, Ltd. | OHV | Class II | 2023-03-14 |
| K213247 | JETT PLASMA Medical II | Compex, Spol, S.R.O. | QVJ | Class II | 2023-03-14 |
| K221352 | Surgical Face Mask | Wuhan Huashida Protective Products Co., Ltd. | FXX | Class II | 2023-03-13 |
| K222456 | High Protection Surgical Gown | 3A Medical Products Co., Ltd. | FYA | Class II | 2023-03-12 |
| K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm | Gme German Medical Engineering GmbH | GEX | Class II | 2023-03-10 |
| K213906 | extriCARE 1000 Negative Pressure Wound Therapy System | Alleva Medical, Ltd. | OMP | Class II | 2023-03-08 |
| K221209 | PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops | Padm Medical, Inc. | FXX | Class II | 2023-03-08 |
| K230076 | Enhanced AURORA Medical Diode System, and related accessories | Psoria-Shield, Inc. | FTC | Class II | 2023-03-08 |
| K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 | Hans Biomed Corporation | NEW | Class II | 2023-03-07 |
| K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | FYA | Class II | 2023-03-07 |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | NEY | Class II | 2023-03-07 |
| K223232 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | FXX | Class II | 2023-03-06 |
| K230383 | Savvy Surgical Mask - Level 3 | Alg Health, LLC | FXX | Class II | 2023-03-06 |
| K230060 | Light Based Hair Removal Device GP592 | Shenzhen Gsd Tech Co., Ltd. | OHT | Class II | 2023-03-03 |
| K230093 | Disposable 4 Layers Surgical Face Mask | Social Medical Supply, LLC | FXX | Class II | 2023-03-02 |
| K223440 | Plasma Pen (Plasma MD); Plasma Pen (Plasma +) | Plasma Concepts | QVJ | Class II | 2023-03-02 |
| K223352 | Tenderfoot | Accriva Diagnostics, Inc. | FMK | Class II | 2023-03-02 |
| K220014 | RSHOCK | Swims America Corp | PBX | Class II | 2023-03-01 |
| K230308 | Alma Harmony | Alma Lasers, Inc. | GEX | Class II | 2023-03-01 |
| K223618 | IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2023-02-28 |
| K222481 | PuraStat | 3-D Matrix, Inc. | QAU | Class II | 2023-02-28 |
| K223272 | SurBlate Ablation System | Mima-Pro Scientific, Inc. | NEY | Class II | 2023-02-28 |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | Clinical Innovations, LLC | FMK | Class II | 2023-02-24 |
| K230227 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | FTL | Class II | 2023-02-23 |
| K223262 | Renuvion® APR Handpiece | Apyx Medical Corporation | GEI | Class II | 2023-02-23 |
| K221559 | Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 | Stringking | FYA | Class II | 2023-02-23 |
| K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | OHS | Class II | 2023-02-23 |
| K230371 | The Alma Soprano Titanium | Alma Lasers, Inc. | GEX | Class II | 2023-02-22 |
| K223643 | Verifine® Ease Lancing Device, Verifine® Lancing Device | Promisemed Hangzhou Meditech Co., Ltd. | QRL | Class II | 2023-02-21 |
| K220214 | Painless IPL System - KDT750 | Shanghai Omni Laser Skinology Co., Ltd. | ONF | Class II | 2023-02-18 |
| K222226 | EON | Dominion Aesthetic Technologies, Inc. | PKT | Class II | 2023-02-17 |
| K221043 | Doctor Tecar Plus, Doctor Tecar Smart | Mectronic Medicale S.R.L. | PBX | Class II | 2023-02-17 |
| K213844 | Surgical Gown | Bayteks Teknik Tekstil San. VE Tic. A.S. | FYA | Class II | 2023-02-16 |
| K223524 | IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 | Morlaser Shenzhen Co., Ltd. | OHT | Class II | 2023-02-16 |
| K221523 | Tanning Lamp | Unilam Co., Ltd. | LEJ | Class II | 2023-02-15 |
| K223815 | ONE DROP Lancing Device | Stat Medical Devices | QRK | Class II | 2023-02-15 |
| K221874 | Altis Single Incision Sling System | Coloplast A/S | PAH | Class II | 2023-02-15 |
| K213669 | LIGHTSCALPEL LS-4020 | Lightscalpel, Inc. | GEX | Class II | 2023-02-15 |
| K221672 | Creo Electrosurgical System with NP1 Instrument | Creo Medical, Ltd. | NEY | Class II | 2023-02-14 |
| K221527 | StitchKit | Origami Surgical Inc . | GAM | Class II | 2023-02-14 |
| K223263 | Prevena Plus 125 Therapy Unit | 3M | QFC | Class II | 2023-02-13 |
| K223370 | NeatNick Heel Safety Lancet | Facet Technologies, LLC | FMK | Class II | 2023-02-13 |
| K223208 | Safety Lancet | Suzhou Zhenwu Medical Co., Ltd. | FMK | Class II | 2023-02-10 |
| K220435 | SEJONG Surgical Gown Soft | Sejong Healthcare Co., Ltd. | FYA | Class II | 2023-02-10 |
| K223467 | Disposable Isolation Gown | Nanning Tecbod Biological Technology Co., Ltd. | FYC | Class II | 2023-02-10 |
| K223680 | Eneka Pro | Termosalud | GEX | Class II | 2023-02-10 |
| K213853 | RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large | Smith and Nephew Medical Limited | OMP | Class II | 2023-02-10 |
| K221223 | extriCARE® 3000 Negative Wound Pressure Therapy System | Alleva Medical Devices | OMP | Class II | 2023-02-09 |
| K220505 | ATTIVA | Italian Engineering S.R.L. | GEI | Class II | 2023-02-09 |
| K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Technology Co., Ltd. | FYC | Class II | 2023-02-08 |
| K222685 | NIRA Model 2 | Dermal Photonics Corp | OHS | Class II | 2023-02-08 |
| K223686 | Medical Protective Masks | Qinhuangdao Taizhi Medical Technology Co., Ltd. | FXX | Class II | 2023-02-07 |
| K220996 | Duoblade | Cnc Technologies | GEI | Class II | 2023-02-03 |
| K220126 | Geonic Nasal Aspirator, Geonic Nasal Cleaner | Geon Corporation | BTA | Class II | 2023-02-02 |
| K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co., Ltd. | GEX | Class II | 2023-02-01 |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories | Gyrus Acmi, Inc. | GEX | Class II | 2023-01-27 |
| K222403 | Surgical Gown | Guangzhou Fuzelong Hygiene Material Co., Ltd. | FYA | Class II | 2023-01-26 |
| K223588 | PALLAS Premium | Laseroptek Co., Ltd. | GEX | Class II | 2023-01-26 |
| K221424 | Sterile Surgical Powder Free Latex Glove | New Era Medicare Sdn. Bhd. | KGO | Class I | 2023-01-26 |
| K223314 | Disposable Blood Lancets | Huaian Hening Medical Instruments Co., Ltd. | QRK | Class II | 2023-01-25 |
| K222801 | Safety Lancet | Sarstedt AG & CO KG | FMK | Class II | 2023-01-25 |
| K223313 | Disposable Safety Lancets | Huaian Hening Medical Instruments Co., Ltd. | FMK | Class II | 2023-01-23 |
| K223158 | LigaSure XP Maryland Jaw Sealer/Divider | Covidien, LLC | GEI | Class II | 2023-01-23 |
| K222832 | Sentimag System | Endomagnetics Ltd., | NEU | Class II | 2023-01-21 |
| K223404 | Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V | Quanta System Spa | GEX | Class II | 2023-01-20 |
| K221419 | TD-5010 Lancing Device and TD-5084 Sterile Lancets | Gostar Co., Ltd. | QRL | Class II | 2023-01-20 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.