Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 42
- Latest Decision
- 2019-12-04
Clearances · page 28 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K192430 | Epic 980 | Biolase, Inc. | GEX | Class II | 2019-12-04 |
| K191371 | MolecuLight i:X | MolecuLight, Inc. | QJF | Class II | 2019-12-04 |
| K192528 | CO2 Laser Therapy System | Shangdong Huamei Technology Co., Ltd. | GEX | Class II | 2019-12-03 |
| K193009 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | FMK | Class II | 2019-12-03 |
| K183371 | Deka Tiac 1 | El..En. Electroic Engineering Spa | PBX | Class II | 2019-12-03 |
| K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip | Cardinal Health200, LLC | FXX | Class II | 2019-12-02 |
| K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co., Ltd. | FMK | Class II | 2019-12-02 |
| K192105 | Innonix Antiviral Child's Face Mask | Innonix Technologies Limited | OUK | Class II | 2019-11-29 |
| K192519 | Multi-modality workstation | Beijing Superlaser Technology Co., Ltd. | ONF | Class II | 2019-11-27 |
| K191961 | OrthoGold | Tissue Regeneration Technologies | PZL | Class II | 2019-11-26 |
| K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) | Kci USA, Inc. | OMP | Class II | 2019-11-22 |
| K190331 | Applied Medical Laparoscopic Linear Cutter | Applied Medical Resources Corporation | GDW | Class II | 2019-11-22 |
| K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories | Us Medical Innovations, LLC | GEI | Class II | 2019-11-21 |
| K192269 | TwinScan 808/755 Laser System | Gme German Medical Engineering GmbH | GEX | Class II | 2019-11-19 |
| K182732 | JTL-250-01 | Jointechlabs, Inc. | MUU | Class II | 2019-11-18 |
| K192331 | LaseMD LEO Laser System | Lutronic Global | GEX | Class II | 2019-11-12 |
| K192432 | IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 | Shenzhen Bosidin Technology Co., Ltd. | OHT | Class II | 2019-11-08 |
| K191564 | Progenikine Concentrating System 25 mL System | Emcyte Corporation | MUU | Class II | 2019-11-07 |
| K191361 | DemeDIOX Barbed Absorbable Surgical Suture | Demetech Corporation | NEW | Class II | 2019-11-07 |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. | OCL | Class II | 2019-11-04 |
| K191693 | BC-5 | Reveallux, Corp | GEX | Class II | 2019-11-01 |
| K190119 | Foryou NPWT Dressing Kit | 4l Health Co., Ltd. | OMP | Class II | 2019-11-01 |
| K190747 | Claritag | Dgi Technologies | GEH | Class II | 2019-10-31 |
| K192867 | Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) | Bovie Medical Corporation Dba Apyx Medical Corporation | GEI | Class II | 2019-10-31 |
| K191855 | EmFace Device | Inmode MD , Ltd. | PBX | Class II | 2019-10-29 |
| K191881 | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun | Kbl GmbH | LEJ | Class II | 2019-10-28 |
| K182605 | HS AMICA devices family | H.S Hospital Service S.P.A | GEI | Class II | 2019-10-28 |
| K192518 | Reusable Monopolar Active Cord | Us Endoscopy | GEI | Class II | 2019-10-25 |
| K190632 | Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein | Lenora Glove Pvt , Ltd. | KGO | Class I | 2019-10-24 |
| K192728 | Agnes | Agnes Medical Co., Ltd. | GEI | Class II | 2019-10-24 |
| K182743 | Patient-Specific Airway Stent | New Cos, Inc. | NWA | Class II | 2019-10-23 |
| K191373 | VICRYL Mesh | ETHICON, Inc. | FTL | Class II | 2019-10-22 |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter | Vein 360, LLC | NUJ | Class II | 2019-10-22 |
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) | Aziyo Biologics, Inc. | FTM | Class II | 2019-10-21 |
| K181896 | LIPOcel | Jeisys Medical, Inc. | OHV | Class II | 2019-10-18 |
| K192566 | Reach and CQ'ENCE Circular Staplers | Reach Surgical, Inc. | GDW | Class II | 2019-10-17 |
| K183503 | EasyMark Tissue Marker | Inrad, Inc. | NEU | Class II | 2019-10-17 |
| K191942 | MT One Diamond | M&T S.R.L. | GEX | Class II | 2019-10-17 |
| K192194 | TotalShield II Surgical Helmet System | Zimmer Surgical, Inc. | FYA | Class II | 2019-10-15 |
| K190937 | Echelon Endopath Staple Line Reinforcement | Ethicon Endo-Surgery, LLC | OXC | Class II | 2019-10-14 |
| K191542 | Apyx Plasma/RF Handpiece | Bovie Medical Corporation Dba Apyx Medical Corporation | GEI | Class II | 2019-10-11 |
| K192235 | AEON Laparoscopic Instruments | Lexington Medical, Inc. | GEI | Class II | 2019-10-11 |
| K190319 | Waterlase Laser System Family | Biolase, Inc. | GEX | Class II | 2019-10-10 |
| K191174 | Mercy babyTAPE | Children'S Mercy Hospital | PIR | Class I | 2019-10-10 |
| K190386 | KTA Adipose Treatment Kit | Stemics S.A.S | MUU | Class II | 2019-10-10 |
| K192185 | The Cellfina System | Ulthera, Inc. | OUP | Class II | 2019-10-09 |
| K191448 | Barrier Sleeves | Ivoclar Vivadent, AG | PEM | Class II | 2019-10-08 |
| K182773 | Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps | Faulhaber Pinzetten Ohg | GEI | Class II | 2019-10-08 |
| K192128 | Sutter Arrowtip Monopolar Electrodes | Sutter Medizintechnik GmbH | GEI | Class II | 2019-10-04 |
| K190820 | Aimanfun Lumea Comfort | Kam Yuen Plastic Products , Ltd. | OHT | Class II | 2019-10-02 |
| K191526 | Cardioblate CryoFlex Surgical Ablation System | Medtronic, Inc. | OCL | Class II | 2019-10-01 |
| K192112 | FlexBand Plus | International Life Sciences | FTL | Class II | 2019-09-27 |
| K182722 | XLR8 Abdominal Wound Dressing Kit | Genadyne Biotechnologies | OMP | Class II | 2019-09-27 |
| K192371 | BioZorb SP Marker | Focal Therapeutics | NEU | Class II | 2019-09-26 |
| K191545 | Exogenesis Hernia Mesh | Exogenesis Corporation | FTL | Class II | 2019-09-26 |
| K183190 | NuStat | Beeken Biomedical, LLC | POD | Class II | 2019-09-25 |
| K192010 | SmoothSkin BARE+ | Cyden Limited | OHT | Class II | 2019-09-24 |
| K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord | Maquet Cardiovascular, LLC | GEI | Class II | 2019-09-17 |
| K183708 | Poly Clear | Medtek Skincare, LLC | OLP | Class II | 2019-09-17 |
| K190308 | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) | Amd Medicom, Inc. | OXZ | Class II | 2019-09-17 |
| K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | Quanta System Spa | GEX | Class II | 2019-09-17 |
| K191685 | PicoWay Laser System | Candela Corporation | GEX | Class II | 2019-09-16 |
| K190932 | RFID Localization System | Health Beacons, Inc. | NEU | Class II | 2019-09-13 |
| K191599 | NICO Myriad NOVUS | Nico Corporation | GEI | Class II | 2019-09-13 |
| K191518 | CO2 Laser System | Shenzhen Gsd Tech Co., Ltd. | GEX | Class II | 2019-09-12 |
| K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | OHS | Class II | 2019-09-12 |
| K191355 | 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask | 3M Healthcare | FXX | Class II | 2019-09-11 |
| K181614 | Sterling Supreme Diode Laser | CAO Group, Inc. | GEX | Class II | 2019-09-10 |
| K181602 | Pioneer Elite Diode Laser | CAO Group, Inc. | GEX | Class II | 2019-09-10 |
| K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | PEM | Class II | 2019-09-10 |
| K191421 | Sofacia System | Sofwave Medical, Ltd. | OHV | Class II | 2019-09-09 |
| K181601 | Precise SHP Diode Laser | CAO Group, Inc. | GEX | Class II | 2019-09-09 |
| K192160 | EVO Platform | Quanta System Spa | GEX | Class II | 2019-09-06 |
| K190499 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | MVR | Class II | 2019-09-06 |
| K182355 | Secret RF Smartcure Applicator with electrodes | Ilooda Co,., Ltd. | GEI | Class II | 2019-09-06 |
| K191528 | Venus Legacy Pro Device | Venus Concept USA, Inc. | GEI | Class II | 2019-09-06 |
| K183563 | Holinwon 30 | Wontech Co., Ltd. | GEX | Class II | 2019-09-05 |
| K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | Antarma, LLC Dba Golnit Sutures | NBY | Class II | 2019-09-04 |
| K191070 | Signia Small Diameter Reloads | Covidien | GDW | Class II | 2019-09-04 |
| K191554 | LightWalker Laser System Family | Fotona D.O.O. | GEX | Class II | 2019-08-30 |
| K191732 | Sutter RaVoR Bipolar Electrodes | Sutter Medizintechnik GmbH | GEI | Class II | 2019-08-30 |
| K192035 | EvaQMax Smoke Evacuation System | Bio Protech, Inc. | FYD | Class II | 2019-08-29 |
| K183122 | 810nm Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | GEX | Class II | 2019-08-25 |
| K191130 | Customized Contour Implant | Implantech Associates, Inc. | FWP | Class II | 2019-08-23 |
| K182950 | Acare Suction Unit | Acare Technology Co., Ltd. | JCX | Class II | 2019-08-23 |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | AtriCure, Inc. | PZX | Class II | 2019-08-21 |
| K191349 | 980nm Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | GEX | Class II | 2019-08-16 |
| K183536 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | Hartalega NGC Sdn. Bhd. | KGO | Class I | 2019-08-16 |
| K190264 | Viola | Meditime Co., Ltd. | NEW | Class II | 2019-08-15 |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG | FWP | Class II | 2019-08-15 |
| K190689 | SignalMark Breast Marker | View Point Medical, Inc. | NEU | Class II | 2019-08-14 |
| K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Accessories) | Olympus Surgical Technologies America | GEX | Class II | 2019-08-09 |
| K183112 | DiLumen Endolumenal Interventional Knife (DiLumen IK) | Lumendi, LLC | GEI | Class II | 2019-08-02 |
| K191321 | Primelase Excellence | High Technology Products S.L.U | GEX | Class II | 2019-08-02 |
| K191611 | Diode Laser Therapy Systems | Wingderm Electro-Optics , Ltd. | GEX | Class II | 2019-07-31 |
| K190777 | DemeTECH DemeFORCE Nonabsorbable Surgical Suture | Demetech Corporation | GAT | Class II | 2019-07-31 |
| K191773 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | OWT | Class II | 2019-07-31 |
| K190891 | Fluobeam LX | Fluoptics | QDG | Class II | 2019-07-31 |
| K191484 | Renuvion/J-Plasma Precise Handpiece | Apyx Medical Corporation(Formerly Bovie Medical Corporation) | GEI | Class II | 2019-07-30 |
| K191328 | Megadyne Foot Switch | Megadyne Medical Products, Inc. | FYD | Class II | 2019-07-26 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.