Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 27
- Latest Decision
- 2020-12-17
Clearances · page 25 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K203303 | Emprint SX Ablation Platform with Thermosphere Technology | Covidien, LLC | NEY | Class II | 2020-12-17 |
| K201594 | Primelase Excellence | High Technology Products S.L.U | GEX | Class II | 2020-12-17 |
| K203097 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | NEU | Class II | 2020-12-16 |
| K202029 | Medical Surgical Mask | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | FXX | Class II | 2020-12-16 |
| K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | FTC | Class II | 2020-12-15 |
| K202827 | 308nm Excimer UV-light Skin Therapy System | Shenzhen Gsd Tech Co., Ltd. | FTC | Class II | 2020-12-15 |
| K202601 | Single-use Sterile medical laser fiber | Realton (Suzhou) Medical Technology Co., Ltd. | GEX | Class II | 2020-12-15 |
| K201735 | PlaDuo System | ShenB Co., Ltd. | GEI | Class II | 2020-12-14 |
| K202467 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads | Fengh Medical Co., Ltd. | GDW | Class II | 2020-12-14 |
| K201629 | Medical Face Mask | Shandong Shengquan New Material Co., Ltd. | FXX | Class II | 2020-12-14 |
| K201893 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co., Ltd. | FXX | Class II | 2020-12-09 |
| K202247 | V30 system, V20 system, V10 system, V-VR Hand piece | Viora , Ltd. | PBX | Class II | 2020-12-09 |
| K202701 | GIA Stapler with Tri-Staple Technology | Covidien | GDW | Class II | 2020-12-07 |
| K201183 | Vortex Radial Spray Catheter | CSA Medical, Inc. | GEH | Class II | 2020-12-07 |
| K201729 | Medical Mask | Zhende Medical Co., Ltd. | FXX | Class II | 2020-12-03 |
| K192970 | SLIMUS | Hironic Co., Ltd. | PKT | Class II | 2020-12-01 |
| K202069 | BASE4 Disposable Medical Mask | Base4 Group, Inc. | FXX | Class II | 2020-12-01 |
| K201687 | Avenda Health Treatment System | Avenda Health, Inc. | GEX | Class II | 2020-11-30 |
| K200372 | Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil | Modern Medical Equipment Manufacturing, Ltd. | GEI | Class II | 2020-11-30 |
| K192406 | AveCure BT Microwave Ablation System | Medwaves, Inc. | NEY | Class II | 2020-11-25 |
| K202250 | Dermatological Carbon Dioxide Laser Systems | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | GEX | Class II | 2020-11-25 |
| K201622 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | FXX | Class II | 2020-11-24 |
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene | Lsi Solutions, Inc. | GAS | Class II | 2020-11-24 |
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | Lsi Solutions | GAS | Class II | 2020-11-24 |
| K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | Pentax of America, Inc. | GEH | Class II | 2020-11-24 |
| K200931 | RF Surgical Generator | Fulwell, LLC | GEI | Class II | 2020-11-24 |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip Applier | M/s. Meril Endo Surgery Private Limited. | FZP | Class II | 2020-11-23 |
| K201991 | Medical surgical mask | Shenzhen Everwin Precision Technology Co., Ltd. | FXX | Class II | 2020-11-23 |
| K202090 | Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | Molnlycke Health Care Us, LLC | KGO | Class I | 2020-11-22 |
| K202139 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | FXX | Class II | 2020-11-20 |
| K202962 | Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft | New Deantronics Taiwan , Ltd. | GEI | Class II | 2020-11-20 |
| K202980 | Laser Therapy Device | Shenzhen Leaflife Technology Co., Ltd. | GEX | Class II | 2020-11-19 |
| K202172 | StarWalker | Fotona D.O.O. | GEX | Class II | 2020-11-19 |
| K202442 | Carewear Firefly Wrinkle Reduction | Carewear Corp. | OHS | Class II | 2020-11-19 |
| K200693 | K2 MOBILE | Hulaser, Inc. | GEX | Class II | 2020-11-19 |
| K202503 | Chrome | Quanta System Spa | GEX | Class II | 2020-11-18 |
| K200472 | Viveve System | Viveve Medical, Inc. | GEI | Class II | 2020-11-18 |
| K202449 | Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein | Medline Industries, Inc. | KGO | Class I | 2020-11-18 |
| K202758 | Nd: YAG Laser Therapy Systems HM-YL900 | Shangdong Huamei Technology Co., Ltd. | GEX | Class II | 2020-11-16 |
| K200081 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | NEY | Class II | 2020-11-13 |
| K192621 | Medical RF | Triworks Group Srl | GEI | Class II | 2020-11-06 |
| K191940 | Palm NRG cellulite and muscle toning body device | Heat IN A Click | PBX | Class II | 2020-11-03 |
| K203032 | IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle | Galil Medical, Inc. | GEH | Class II | 2020-11-02 |
| K202558 | Ellusa Bipolar Wands | Ellusa, LLC | GEI | Class II | 2020-11-02 |
| K202562 | Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set | Ellusa, LLC | GEI | Class II | 2020-11-02 |
| K202157 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack | Smith & Nephew Medical Limited | OMP | Class II | 2020-10-30 |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology System | Aesculap, Inc. | GEI | Class II | 2020-10-30 |
| K202864 | Tri-Staple 2.0 Reloads | Covidien | GDW | Class II | 2020-10-28 |
| K200003 | NP1 Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | NEY | Class II | 2020-10-28 |
| K201475 | Ultimate Contour, Ultimate Contour Mini | CAO Group, Inc. | PBX | Class II | 2020-10-28 |
| K200223 | PocketDoc Micro Wound Therapy System | Pensar Medical, LLC | OMP | Class II | 2020-10-23 |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. | GEX | Class II | 2020-10-22 |
| K192771 | C4 Fiducial Marker | C4 Imaging, LLC | NEU | Class II | 2020-10-21 |
| K201884 | ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm | Microline Surgical, Inc. | GEI | Class II | 2020-10-21 |
| K201139 | WEGO-PDO Barbed Suture | Foosin Medical Supplies Inc., Ltd. | NEW | Class II | 2020-10-20 |
| K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | OWY | Class II | 2020-10-19 |
| K201129 | Medline Smoke Evacuation Pencil | Medline Industires, Inc. | GEI | Class II | 2020-10-16 |
| K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm | Ethicon Endo-Surgery, LLC | GDW | Class II | 2020-10-15 |
| K202041 | Opera Evo | Quanta System Spa | GEX | Class II | 2020-10-15 |
| K201882 | AEON Endoscopic Stapler | Lexington Medical, Inc. | GDW | Class II | 2020-10-09 |
| K201380 | Livocare Surgical Mask | Andon Health Co, Ltd. | FXX | Class II | 2020-10-07 |
| K202114 | CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 | Bolder Surgical, LLC | GEI | Class II | 2020-10-06 |
| K190707 | Arthrex SoftStitch | Arthrex, Inc. | GAT | Class II | 2020-10-02 |
| K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs | Hartalega Sdn Bhd | KGO | Class I | 2020-10-02 |
| K201221 | Electrosurgical Generator | New Deantronics Taiwan , Ltd. | GEI | Class II | 2020-09-28 |
| K202277 | Surgical Face Mask | Jiangxi 3l Medical Products Group Co., Ltd. | FXX | Class II | 2020-09-25 |
| K201260 | Dermal Cooling System | R2 Technologies, Inc. | GEH | Class II | 2020-09-24 |
| K201224 | Electrosurgical Generator and Accessories | Medrange | GEI | Class II | 2020-09-18 |
| K202463 | Disposable Surgical Mask | Unisources Group, LLC | FXX | Class II | 2020-09-18 |
| K201691 | Single-Use Surgical Mask With Ear Loop | Qiqihar Hengxin Medical Supplies, Ltd. | FXX | Class II | 2020-09-17 |
| K201686 | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide | ETHICON, Inc. | OTN | Class II | 2020-09-17 |
| K201774 | Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs | Pt. Medisafe Technologies | KGO | Class I | 2020-09-16 |
| K202242 | HS Fiber | Riverpoint Medical, LLC | GAT | Class II | 2020-09-10 |
| K201731 | Diode Laser Body Sculpture System | Shanghai Apolo Medical Technology Co., Ltd. | PKT | Class II | 2020-09-10 |
| K201738 | SubNovii Advanced Plasma Technology | Cartessa Aesthetics | GEI | Class II | 2020-09-10 |
| K201829 | SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) | Medline Industries, Inc. | KGO | Class I | 2020-09-09 |
| K192423 | MINT Product Family | Hans Biomed Corporation | NEW | Class II | 2020-09-09 |
| K201470 | Disposable Medical Face Mask | Jkh USA, LLC | FXX | Class II | 2020-09-08 |
| K202354 | Surgical Mask-Model Number CW01 | Hunan Heng Chang Pharmaceutical Co., Ltd. | FXX | Class II | 2020-09-08 |
| K201517 | Plain Surgical Mask | Aok Tooling Limited | FXX | Class II | 2020-09-04 |
| K201537 | Protective Face Mask for Medical Use | Shandong Shengquan New Material Co., Ltd. | FXX | Class II | 2020-09-04 |
| K201203 | Cliq Aspirator | Anest Iwata Sparmax Co., Ltd. | BTA | Class II | 2020-09-03 |
| K192452 | Lyograft | B. Bruan Surgical, SA | FTM | Class II | 2020-09-03 |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | Aesculap, Inc. | FZP | Class II | 2020-09-02 |
| K200926 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | PZL | Class II | 2020-08-28 |
| K192953 | APTOS Threads Polypropylene Surgical Sutures | Aptos, LLC | GAW | Class II | 2020-08-27 |
| K200796 | Emprint Ablation System with Thermosphere Technology | Covidien, LLC | NEY | Class II | 2020-08-26 |
| K200923 | Single-use Surgical Mask | Byd Precision Manufacturer Co., Ltd. | FXX | Class II | 2020-08-26 |
| K201549 | Motex Anti-Fog Surgical Face Mask | Modern Healthcare Corp. | FXX | Class II | 2020-08-26 |
| K201056 | NeuroBlate System | Monteris Medical, Inc. | GEX | Class II | 2020-08-21 |
| K193201 | BTL-785F | Btl | GEI | Class II | 2020-08-21 |
| K201137 | Asept Surgical Face Mask | Pfm Medical, Inc. | FXX | Class II | 2020-08-19 |
| K192275 | invisa-RED ELITE | IR Technology, LLC | OLI | Class II | 2020-08-19 |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | MQR | Class II | 2020-08-17 |
| K192620 | SNA-001 Silver Photoparticle Topical Gel | Sienna Biopharmaceuticals, Inc. | QCY | Class II | 2020-08-12 |
| K201871 | Surgical Mask | C & S Paper Yunfu Co., Ltd. | FXX | Class II | 2020-08-12 |
| K201637 | Aurora Evacuator +Coag | Rebound Therapeutics | GEI | Class II | 2020-08-12 |
| K200359 | NuEra Tight, NuEra Tight EMS | Bios S.R.L. | PBX | Class II | 2020-08-11 |
| K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice | Varian Medical Systems, Inc. | GEH | Class II | 2020-08-11 |
| K201143 | VICRYL Mesh | ETHICON, Inc. | FTL | Class II | 2020-08-06 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.