Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 38
- Latest Decision
- 2023-07-21
Clearances · page 13 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K231474 | Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation | OLI | Class II | 2023-07-21 |
| K231790 | The InMode System with the Morpheus8 Applicators | InMode , Ltd. | GEI | Class II | 2023-07-20 |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | AngioDynamics, Inc. | GEX | Class II | 2023-07-20 |
| K230037 | BACK 3 | Swims America Corp | PBX | Class II | 2023-07-19 |
| K230077 | LaserME | Neauvia North America | GEX | Class II | 2023-07-17 |
| K230395 | Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) | Durio Ppe Sdn Bhd | FXX | Class II | 2023-07-17 |
| K230269 | Ultraflex Tracheobronchial Stent System | Boston Scientific Corporation | JCT | Class II | 2023-07-14 |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products, Inc. | NEU | Class II | 2023-07-13 |
| K223388 | Invia® Integrated Dressing | Medela AG | OMP | Class II | 2023-07-07 |
| K230968 | VYBE RF Electrosurgical System | ShenB Co., Ltd. | GEI | Class II | 2023-07-06 |
| K222220 | SpinMedix Absorbable Fibrous Membrane | Celestray Biotech Company, LLC., | OWW | Class II | 2023-07-06 |
| K230510 | MyEllevate | Cynosure, LLC | GAT | Class II | 2023-07-06 |
| K220980 | Tissue Approximation System (TAS) | Tas Medical, Inc. | GAR | Class II | 2023-07-05 |
| K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | Light Tree Ventures Europe B.V. | OLP | Class II | 2023-07-03 |
| K230025 | IVYLASER Handhold Hair Removal Machine | Ivylaser (Beijing) Technology Co.,Ltd | OHT | Class II | 2023-07-03 |
| K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) | Cardinalhealth | FXX | Class II | 2023-07-03 |
| K223135 | AblatePal Radiofrequency Ablation System | Compal Electronics, Inc. | GEI | Class II | 2023-06-30 |
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | OTN | Class II | 2023-06-29 |
| K213046 | AceConnex Pre-Sutured Fascia | Allosource | GAT | Class II | 2023-06-27 |
| K231124 | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) | Owen Mumford, Ltd. | FMK | Class II | 2023-06-27 |
| K231215 | IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S | Zhongshan Qizhe Technology Co., Ltd. | OHT | Class II | 2023-06-26 |
| K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) | ArthroCare Corporation | GEI | Class II | 2023-06-26 |
| K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | NEY | Class II | 2023-06-26 |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | Rti Surgical, Inc. | GAT | Class II | 2023-06-23 |
| K223871 | Miria Skin Treatment System | AVAVA, Inc. | ONG | Class II | 2023-06-22 |
| K231131 | Diode Laser Body Sculpture Systems | Shanghai Bele Medical Technology Co.,Ltd | PKT | Class II | 2023-06-22 |
| K230599 | TargetCool | Recensmedical, Inc. | GEH | Class II | 2023-06-22 |
| K223033 | Tixel® 2 System | Novoxel , Ltd. | GEI | Class II | 2023-06-21 |
| K231212 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | GEI | Class II | 2023-06-21 |
| K222999 | Surgical Gown | Hubei Woozon Healthcare Co., Ltd. | FYA | Class II | 2023-06-16 |
| K230473 | IPL Hair Removal Device Models: MLY-T069 | Miley Technology (Hebei) Co., Ltd. | OHT | Class II | 2023-06-15 |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | MUM | Class II | 2023-06-14 |
| K230759 | SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) | Bosungmeditech Co., Ltd. | QRK | Class II | 2023-06-13 |
| K201153 | Tisuthes e-PTFE Surgical Patch | Shanghai Suokang Medical Implants Co., Ltd. | OWR | Class II | 2023-06-13 |
| K221888 | Genadyne Hybrid Foam Dressings | Genadyne Biotechnologies, Inc. | OMP | Class II | 2023-06-12 |
| K223669 | SecurePortIV Advanced Catheter Securement Adhesive | Adhezion Biomedical, LLC | NZP | Class II | 2023-06-12 |
| K230293 | TheraFace Mask | Therabody, Inc. | OHS | Class II | 2023-06-09 |
| K230586 | Renuvion® Micro Handpiece | Apyx Medical Corporation | GEI | Class II | 2023-06-09 |
| K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | Zhejiang Curaway Medical Technology Co., Ltd. | OAB | Class II | 2023-06-08 |
| K230659 | Zionic Aesthetic | Termosalud | PBX | Class II | 2023-06-08 |
| K212734 | Diode laser therapy device | Triangel Rsd Limited | GEX | Class II | 2023-06-06 |
| K230660 | AviClear Laser System | Cutera, Inc. | GEX | Class II | 2023-06-06 |
| K212733 | Diode laser therapy device | Beijing Star New Tech Co., Ltd. | GEX | Class II | 2023-06-06 |
| K230498 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | GEI | Class II | 2023-06-05 |
| K223822 | ACTIVBRAID | Embody, Inc. | GAT | Class II | 2023-06-02 |
| K231309 | SCAR 3 | El.En Electroinc Engineering Spa | GEX | Class II | 2023-06-02 |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | Candela Corporation | GEX | Class II | 2023-06-01 |
| K230617 | Surgical Face Mask (L 175*95mm) | Henan Chaoya Medical Equipment Co., Ltd. | FXX | Class II | 2023-06-01 |
| K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros, Ltd. | FTL | Class II | 2023-05-31 |
| K222556 | BTL-785X | BTL Industries, Inc. | GEI | Class II | 2023-05-31 |
| K230593 | Victan | Jiangsu Haize Medical Scientific Development Co., Ltd. | GEI | Class II | 2023-05-30 |
| K221897 | Hydrozid Precise | Bibawo Medical A/S | GEH | Class II | 2023-05-30 |
| K230739 | Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 | Shenzhen Ionka Medical Technology Co., Ltd. | OHT | Class II | 2023-05-26 |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | KGO | Class I | 2023-05-26 |
| K230580 | Diode Laser System | Smedtrum Medical Technology Co., Ltd. | GEX | Class II | 2023-05-26 |
| K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | OWW | Class II | 2023-05-26 |
| K213256 | ThermoTK | Zimmer Medizinsysteme GmbH | PBX | Class II | 2023-05-25 |
| K230373 | HELIOS 785 Pico | Laseroptek Co., Ltd. | GEX | Class II | 2023-05-22 |
| K230460 | Laser Thermal Therapy Kit | Elesta S.P.A | GEX | Class II | 2023-05-22 |
| K222545 | Disposable Medical Mask | Guangzhou Fuzelong Hygiene Material Co., Ltd. | FXX | Class II | 2023-05-19 |
| K222356 | Claritag Advanced | Dgi Technologies | GEH | Class II | 2023-05-18 |
| K230432 | Single Use Bipolar Forceps | Hg Innovations, Ltd. | GEI | Class II | 2023-05-18 |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company | KKX | Class II | 2023-05-18 |
| K230448 | DeepX DermoSight Dermatoscope | Deepx Health, LLC | PSN | Class II | 2023-05-17 |
| K223893 | Infrared Heat (Model: E0221) | Light Tree Ventures Europe B.V. | OHS | Class II | 2023-05-16 |
| K223147 | myLEDmask | Myblend | OHS | Class II | 2023-05-14 |
| K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | KGO | Class I | 2023-05-13 |
| K231063 | SOMAVAC® 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | BTA | Class II | 2023-05-12 |
| K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | OWY | Class II | 2023-05-11 |
| K222487 | Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. | GDW | Class II | 2023-05-08 |
| K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | OHS | Class II | 2023-05-05 |
| K223805 | Agnes | Agnes Medical Co., Ltd. | GEI | Class II | 2023-05-04 |
| K220322 | Pollogen STOP U Model UXV Device | Pollogen, Ltd. | PAY | Class II | 2023-05-04 |
| K230340 | Lucas Plus | Amt Engineering Co., Ltd. | GEX | Class II | 2023-05-04 |
| K222388 | swiftPro System | Emblation , Ltd. | NEY | Class II | 2023-05-04 |
| K223907 | NuEra Tight RF Model APMD145.M70-US | Bios S.R.L. | PBX | Class II | 2023-05-02 |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Teleflex Medical | FZP | Class II | 2023-04-28 |
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | OHS | Class II | 2023-04-28 |
| K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter | Conmed Corporation | GEI | Class II | 2023-04-27 |
| K230272 | Renuvion® APR Handpiece | Apyx Medical Corporation | GEI | Class II | 2023-04-27 |
| K230911 | Braun Skin i.expert | Cyden Limited | OHT | Class II | 2023-04-27 |
| K222352 | Epildream HP 4000 MED | D.E.A Project S.R.1. | GEX | Class II | 2023-04-27 |
| K230539 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | GEI | Class II | 2023-04-27 |
| K230499 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | GEI | Class II | 2023-04-26 |
| K223932 | SafeAir combi (SFR-combi-US) | Lina Medical Aps | GEI | Class II | 2023-04-26 |
| K230549 | IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG | Shenzhen Xiazhifeng Electronic Co., Ltd. | OHT | Class II | 2023-04-25 |
| K222210 | AEON Endoscopic Stapler | Lexington Medical, Inc. | GDW | Class II | 2023-04-21 |
| K230816 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | ONF | Class II | 2023-04-21 |
| K230819 | OmniGuide RFID Surgical Laser Fibers | Omni-Guide Holdings, Inc. | GEX | Class II | 2023-04-21 |
| DEN220082 | Breast Implant Removal Device (BIRD) | Gaylord Solutions, LLC | QVS | Class II | 2023-04-20 |
| K223201 | TAP Lancet | Yourbio Health, Inc. | FMK | Class II | 2023-04-19 |
| K221042 | Renova RP Centesis Pump | Gi Supply, Inc. | BTA | Class II | 2023-04-19 |
| K230090 | Diode Laser Hair Removal | Wuhan Lotuxs Technology Co., Ltd. | OHT | Class II | 2023-04-19 |
| K223784 | Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 | Deltronix Equipamentos Ltda | GEI | Class II | 2023-04-18 |
| K230820 | SofWave System | Sofwave Medical, Ltd. | OHV | Class II | 2023-04-18 |
| K222350 | Sterile Nitrile Surgical Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | KGO | Class I | 2023-04-13 |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) | Ethicon Endo-Surgery, LLC | GEI | Class II | 2023-04-13 |
| K230412 | Symmed Elite Aesthetic | Termosalud | PBX | Class II | 2023-04-13 |
| K230360 | IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02 | Shenzhen Jizhimei Technology Co., Ltd. | OHT | Class II | 2023-04-10 |
| K230122 | IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2023-04-10 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.