Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 34
- Latest Decision
- 2023-01-19
Clearances · page 15 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K223540 | AvalancheLase Family | Fotona D.O.O. | GEX | Class II | 2023-01-19 |
| K221522 | HF-cables (resusable) | Olympus Winter & Ibe GmbH | GEI | Class II | 2023-01-19 |
| K211197 | Disposable Endoscopic Cutter Stapler and Cartridge | Changzhou Waston Medical Appliance Co., Ltd. | GDW | Class II | 2023-01-19 |
| K223107 | MOLLI 2 | Molli Surgical, Inc. | NEU | Class II | 2023-01-18 |
| K223222 | Plasma IQ | Neauvia North America, Inc. | GEI | Class II | 2023-01-17 |
| K221682 | Ideal Med Pro 3-Ply Disposable Face Mask | Jsn Holdings, LLC | FXX | Class II | 2023-01-13 |
| K223183 | Light-Guide Cables | Olympus Winter & Ibe GmbH | HBI | Class II | 2023-01-13 |
| K223480 | Medipoint Blood Lancets | Medipoint Holdings, LLC | QRK | Class II | 2023-01-13 |
| K221873 | NeoGen PSR System | Energist Limited | GEI | Class II | 2023-01-12 |
| K203380 | Disposable Surgical Face Mask | Shandong Pop Jeans Intelligent Manufacturing Co., Ltd. | FXX | Class II | 2023-01-06 |
| K213198 | Ax-Surgi Surgical Hemostat | Advamedica, Inc. | POD | Class II | 2023-01-05 |
| K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | FYC | Class II | 2023-01-04 |
| K222221 | DEKA HELIX | El.En Electronic Engineering Spa | GEX | Class II | 2023-01-04 |
| K223685 | SmoothCool HR System | Jeisys Medical, Inc. | GEX | Class II | 2023-01-04 |
| K222483 | Surgical Face Mask | Hubei Woozon Healthcare Co., Ltd. | FXX | Class II | 2023-01-04 |
| K222809 | Medical Disposable Face Masks | Anqing Mayfield Medical Limited | FXX | Class II | 2023-01-03 |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) | AtriCure, Inc. | OCL | Class II | 2022-12-30 |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser System | Solta Medical, Inc. | GEX | Class II | 2022-12-29 |
| K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | QUW | Class II | 2022-12-27 |
| K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | Medtronic, Inc. | OCL | Class II | 2022-12-22 |
| K223482 | reVive Light Therapy® Wrinkle and Acne LED Device | Led Technologies, Inc. | OHS | Class II | 2022-12-21 |
| K213893 | Comfort Gown, Safewear Gown | Xuchang Zhengde Environstar Medical Products Co., Ltd. | FYA | Class II | 2022-12-21 |
| K221070 | DP4 Microneedling device | Equipmed USA, LLC | QAI | Class II | 2022-12-20 |
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | Light Tree Ventures Europe B.V. | OHS | Class II | 2022-12-20 |
| K221011 | AI.ME System | Venus Concept USA, Inc. | QAI | Class II | 2022-12-20 |
| K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | OXF | Class II | 2022-12-19 |
| K223237 | SofWave System | Sofwave Medical, Ltd. | OHV | Class II | 2022-12-16 |
| K213601 | Surgical Mask | Wuhan Zonsen Medical Products Co., Ltd. | FXX | Class II | 2022-12-16 |
| K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets | Becton, Dickinson and Company | FMK | Class II | 2022-12-16 |
| K220520 | PM Excellence SEQUR 100 Surgical Face Mask | Pm Excellence, LLC | FXX | Class II | 2022-12-15 |
| K221891 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | OMP | Class II | 2022-12-14 |
| K220971 | QuikClot Control+ Hemostatic Dressing | Z-Medica, LLC | POD | Class II | 2022-12-14 |
| K222651 | Surgical Face Mask | Xiantao Sanda Industrial Co., Ltd. | FXX | Class II | 2022-12-13 |
| K213105 | Epilaser Absolute | Epilady 2000, LLC | GEX | Class II | 2022-12-13 |
| K221280 | Vesseal | Lydus Medical , Ltd. | GAW | Class II | 2022-12-09 |
| K222916 | US 450 Diode Laser Equipment | Beijing Globalipl Development Co., Ltd. | GEX | Class II | 2022-12-09 |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) | Stryker Instruments | JCX | Class II | 2022-12-09 |
| K221444 | LED Eye Perfector, model: EY-36A, EY-36B | Light Tree Ventures Europe B.V. | OHS | Class II | 2022-12-08 |
| K223045 | 3-Ply Disposable Medical Mask | Wealth Lead Industrial Limited | FXX | Class II | 2022-12-07 |
| K223055 | Disposable Medical Face Mask | Xiantao Zhuobo Industrial Co., Ltd. | FXX | Class II | 2022-12-05 |
| K223369 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 | STERIS Corporation | GEH | Class II | 2022-12-02 |
| K221410 | Maestro Platform | Moon Surgical | FQO | Class I | 2022-12-02 |
| K223218 | Parietene Macroporous Mesh | Sofradim Production | FTL | Class II | 2022-12-02 |
| K222710 | IPL Cooling Hair Removal Device | Shenzhen Siken 3D Technology Development Co., Ltd. | OHT | Class II | 2022-12-01 |
| K221771 | EEA Circular Stapler with Tri-Staple Technology | Covidien | GDW | Class II | 2022-11-30 |
| K212717 | Paneffort AAMI Level 3 Isolation Gown | Paneffort, LLC | FYC | Class II | 2022-11-30 |
| K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | Shandong Lianfa Medical Plastic Products Co. , Ltd. | QRL | Class II | 2022-11-30 |
| K222641 | Signia Small Diameter Reloads Including Regular (Round) Tip Version | Covidien | GDW | Class II | 2022-11-29 |
| K222408 | Disposable Safety Lancet | Beijing Ruicheng Medical Supplies Co., Ltd. | FMK | Class II | 2022-11-29 |
| K223099 | Facet Manatee Reusable Lancing Base | Facet Technologies, LLC | QRL | Class II | 2022-11-28 |
| K221556 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | FTL | Class II | 2022-11-28 |
| K223039 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | GEI | Class II | 2022-11-28 |
| K221815 | Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) | Baisheng Medical Co., Ltd. | GEI | Class II | 2022-11-23 |
| K223292 | TempSure System | Cynosure, LLC | GEI | Class II | 2022-11-23 |
| K222656 | LDE4 Lancing Device | I-Sens, Inc. | QRL | Class II | 2022-11-23 |
| K223068 | Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) | Guangdong Golden Leaves Technology Development Co., Ltd. | FXX | Class II | 2022-11-23 |
| K223041 | Renasys Edge (66803126) | Smith & Nephew Medical Limited | OMP | Class II | 2022-11-22 |
| K213427 | PRIMED Pediatric Facemask | Primed Medical Products, Inc. | OXZ | Class II | 2022-11-22 |
| K221946 | LED Light Therapy Mask (model: MK66R-B) | Light Tree Ventures Europe B.V. | OHS | Class II | 2022-11-22 |
| K222246 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co., Ltd. | QRL | Class II | 2022-11-21 |
| K221268 | SR-1 Skin Treatment System | AVAVA, Inc. | ONG | Class II | 2022-11-21 |
| K222539 | Facet Blood Lancets | Facet Technologies, LLC | QRL | Class II | 2022-11-18 |
| K223003 | Banded Face Mask | Hubei Medlink Healthcare Co., Ltd. | FXX | Class II | 2022-11-18 |
| K222701 | MANTA Laser | Squalus Med , Ltd. | GEX | Class II | 2022-11-18 |
| K223278 | easy Claire | Y & J Bio Co., Ltd. | OHS | Class II | 2022-11-17 |
| K213042 | Supra Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | GEI | Class II | 2022-11-17 |
| K222673 | Alexandrite and Nd:YAG Laser models CANLASE and TORLASE | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | GEX | Class II | 2022-11-17 |
| K222109 | Accure Laser | Accure Acne, Inc. | GEX | Class II | 2022-11-17 |
| K213295 | C.C. LIFE 21 | 21 Equipment S.R.L. | PBX | Class II | 2022-11-17 |
| K222598 | IPL Hair Removal Device | Shenzhen Noble Smart Manufacturing Tech Co., Ltd. | OHT | Class II | 2022-11-17 |
| K211265 | TFX-LT2000 Therapy Light | Toefx, Inc. | PDZ | Class II | 2022-11-17 |
| K220302 | Disposable surgical face mask | Shandong Aida Medical Products Co., Ltd. | FXX | Class II | 2022-11-16 |
| K212812 | Surgical Gown | Xianning Marveldas Protective Articles Co., Ltd. | FYA | Class II | 2022-11-16 |
| K203528 | KNH Surgical Face Mask | Knh Surgical Face Mask | FXX | Class II | 2022-11-16 |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | ETHICON, Inc. | GAM | Class II | 2022-11-15 |
| K222055 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co., Ltd. | FMK | Class II | 2022-11-15 |
| K222915 | Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | GEX | Class II | 2022-11-15 |
| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) | Foshan Nanhai Plus Medical Co, Ltd. | FYA | Class II | 2022-11-14 |
| K222529 | Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | FXX | Class II | 2022-11-14 |
| K222749 | High Fluid-Resistant Surgical and Procedure Mask | AmericaS Supply Chains | FXX | Class II | 2022-11-14 |
| K213294 | Dermal Cooling System | R2 Technologies, Inc. | QPZ | Class II | 2022-11-10 |
| K220794 | 10PL | Tentech Co. , Ltd. | ONF | Class II | 2022-11-10 |
| K222551 | Humask Pro Vision, Humask Pro Vision 3000 | Entreprise Premont, Inc. | FXX | Class II | 2022-11-10 |
| K221139 | Bodygard SFS Surgical Gown Level 4 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri | FYA | Class II | 2022-11-10 |
| K222800 | Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) | Sanhe Laserconn Tech Co., Ltd. | GEX | Class II | 2022-11-07 |
| K222697 | Disposable Medical Face Mask (DF3-001) | Wellmed Dental Medical Supply Co., Ltd. | FXX | Class II | 2022-11-04 |
| K222377 | Led Mask Platinum Md | Cellreturn Co., Ltd. | OHS | Class II | 2022-11-03 |
| K222168 | Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler | Owen Mumford, Ltd. | FMK | Class II | 2022-11-03 |
| K223110 | truSculpt iD | Cutera, Inc. | GEI | Class II | 2022-11-03 |
| K222084 | OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie | Asahi Polyslider Co., Ltd. | FMK | Class II | 2022-11-02 |
| K214090 | Back 3 COLOR | Swims America Corp | PBX | Class II | 2022-11-01 |
| K223270 | POSE Health Care Surgical Mask | America'S Supply Chains | FXX | Class II | 2022-11-01 |
| K211060 | Disposable Surgical Gown Rk-3011C | Xiantao Rhycom Non-Woven Products Co., Ltd. | FYA | Class II | 2022-10-28 |
| K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | Syntheon | PZX | Class II | 2022-10-28 |
| K221521 | Disposable Safety Lancet | SteriLance Medical (Suzhou), Inc. | FMK | Class II | 2022-10-28 |
| K220880 | Arthrex BioSuture | Arthrex, Inc. | GAT | Class II | 2022-10-27 |
| K222032 | NEUROMARK System | Neurent Medical | GEI | Class II | 2022-10-26 |
| K222303 | Unistik® Pro | Owen Mumford, Ltd. | FMK | Class II | 2022-10-25 |
| K212649 | Disposable Surgical Face Mask | Lyncmed Medical Technology (Beijing) Co., Ltd. | FXX | Class II | 2022-10-25 |
| K221783 | SafetiCET Safety Lancet | Nsp Tech Pte, Ltd. | FMK | Class II | 2022-10-24 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.