Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 26
- Latest Decision
- 2022-03-08
Clearances · page 19 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213558 | IPL Hair Removal Device | Ulike Co., Ltd. | ONF | Class II | 2022-03-08 |
| K214087 | Medical Face Mask | Hubei Medlink Healthcare Co., Ltd. | FXX | Class II | 2022-03-08 |
| K220506 | SkinPen Precision System | Crown Aesthetics | QAI | Class II | 2022-03-07 |
| K211639 | BTL-785W | BTL Industries, Inc. | GEI | Class II | 2022-03-07 |
| K213703 | Surgical Gown | Wujiang Tutaike Textiles & Finishing Co., Ltd. | FYA | Class II | 2022-03-04 |
| K213358 | Surgical Mask | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | FXX | Class II | 2022-03-04 |
| K211811 | Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers | Wuxi Beien Surgery Device Co., Ltd. | GDW | Class II | 2022-03-03 |
| K213285 | easy Claire | Y & J Bio Co., Ltd. | OHS | Class II | 2022-03-03 |
| K212698 | Plus Medical Isolation Gown Level 3 | Foshan Nanhai Plus Medical Co, Ltd. | FYC | Class II | 2022-03-02 |
| K203376 | ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G | Medtecs (Taiwan) Corp. | FXX | Class II | 2022-03-02 |
| K213127 | ReNew Disposable Scissor Tips | Microline Surgical, Inc. | GEI | Class II | 2022-03-02 |
| K220006 | angioLOCK Polymer Ligating Clip | A2 Medical Systems, LLC | FZP | Class II | 2022-03-02 |
| K212596 | Sterile Latex Surgical Gloves Powder Free | Amazing Rubber Products Pvt, Ltd. | KGO | Class I | 2022-03-01 |
| K203150 | Cool-tip RF Ablation System E Series | Covidien, LLC | GEI | Class II | 2022-02-25 |
| K211722 | Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares | Canadian Pioneer Medical Technology Corporation | GEX | Class II | 2022-02-25 |
| K214094 | ROKI Surgical Mask | Roki Co., Ltd. | FXX | Class II | 2022-02-24 |
| K220384 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | GEI | Class II | 2022-02-24 |
| K202845 | Bodygard SFS Surgical Gown Level 3 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi | FYA | Class II | 2022-02-24 |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | ETHICON, Inc. | NEW | Class II | 2022-02-22 |
| K203548 | EndoArmor + Surgical Gown | Boston Scientific Corporation | FYA | Class II | 2022-02-21 |
| K213724 | Medical Surgical Mask | Hunan Zhenheyikang Medical Instrument Co., Ltd. | FXX | Class II | 2022-02-20 |
| K212863 | Surgical Face Mask | Taiwan Comfort Champ Manufacturing Co., Ltd. | FXX | Class II | 2022-02-19 |
| K212366 | Heartland Health Surgical Mask | Heartland Health Products | FXX | Class II | 2022-02-19 |
| K214022 | Accu-Chek Softclix Blood Lancing System | Roche Diabetes Care, Inc. | QRL | Class II | 2022-02-17 |
| K220124 | YandR System, VoluDerm Handpiece, VoluDerm Tips | Pollogen, Ltd. | GEI | Class II | 2022-02-17 |
| K213617 | Surgical Face Mask | Megasoft (China) Co., Ltd. | FXX | Class II | 2022-02-11 |
| K212971 | NPseal | Guard Medical, Inc. | OKO | Class II | 2022-02-10 |
| K220020 | Cryo 7 | Zimmer Medizinsysteme GmbH | GEX | Class II | 2022-02-04 |
| K213569 | HOLLYWOOD SPECTRA Laser System | Lutronic Corporation | GEX | Class II | 2022-02-04 |
| K220071 | Soniquence Reusable Neutral Plate | Soniquence, LLC | GEI | Class II | 2022-02-03 |
| K213554 | Sentient Manufacturing Laser Fiber | Sentient Manufacturing , LLC | GEX | Class II | 2022-02-02 |
| K211228 | Rosso | Quanta System Spa | GEX | Class II | 2022-02-02 |
| K213814 | Viveve 2.0 System | Viveve, Inc. | GEI | Class II | 2022-02-02 |
| K213830 | Home use hair removal device, model: Precise Touch Pro | Iluminage Beauty Co., Limited | OHT | Class II | 2022-02-01 |
| K210727 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | GEI | Class II | 2022-02-01 |
| K212611 | CO2 Laser Equipment | Beijing Globalipl Development Co., Ltd. | GEX | Class II | 2022-02-01 |
| K212120 | Surgical Masks | Hubei Xinxin Non-Woven Co., Ltd. | FXX | Class II | 2022-01-28 |
| K203395 | Platform treatment system | Shanghai Apolo Medical Technology Co., Ltd. | GEX | Class II | 2022-01-28 |
| K213317 | ShinEvac Smoke Evacuation Pencil | Shining World Health Care Co., Ltd. | GEI | Class II | 2022-01-28 |
| K212771 | LightStim Elipsa | Led Intellectual Properties, LLC | OHS | Class II | 2022-01-26 |
| K212610 | Surgical Face Mask | Foshan Nanhai Plus Medical Co, Ltd. | FXX | Class II | 2022-01-26 |
| K210101 | American-Made Surgical Mask | Armbrust, Inc. | FXX | Class II | 2022-01-26 |
| K213692 | SmoothSkin Pure Mini | Cyden Limited | OHT | Class II | 2022-01-26 |
| K213347 | ADI Medical Surgical Face Mask | Asia Dynamics Inc., D/B/A Adi Medical | FXX | Class II | 2022-01-25 |
| K213970 | D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply | Danameco Medical Joint Stock Corporation | FXX | Class II | 2022-01-23 |
| K212111 | Myflon Surgical Mask Level 3 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi | FXX | Class II | 2022-01-23 |
| K213696 | ETHICON Megadyne Electrosurgical Generator | Megadyne Medical Products, Inc. | GEI | Class II | 2022-01-21 |
| K212357 | Surgical isolation gown | Wuhan Zonsen Medical Products Co., Ltd. | FYC | Class II | 2022-01-20 |
| K203161 | Surgical Face Mask | Wuhan Raytex Protection Co., Ltd. | FXX | Class II | 2022-01-20 |
| K212826 | Disposable Medical Mask | Jiangsu Nanfang Medical Co., Ltd. | FXX | Class II | 2022-01-19 |
| K210679 | Medical Face Mask | Wuxi Yushou Medical Appliances Co., Ltd. | FXX | Class II | 2022-01-18 |
| K212994 | Medical Face Mask | Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. | FXX | Class II | 2022-01-17 |
| K211833 | Disposable Medical Face Mask | Zhejiang the Purples Protective Products Co.,Ltd | FXX | Class II | 2022-01-16 |
| K213920 | Kangbeier Surgical Mask (Model: KBR-1001) | Xinxiang Kangbeier Medical Technology Co., Ltd. | FXX | Class II | 2022-01-16 |
| K212478 | Dermatological diode laser system | Beijing Stelle Laser Technology Co., Ltd. | GEX | Class II | 2022-01-14 |
| K212913 | Surgical Face Mask | Jiangxi Ganlong Pharmaceutical Co., Ltd. | FXX | Class II | 2022-01-14 |
| K212093 | Medline Universal Grounding Pad | Medline Industries, Inc. | GEI | Class II | 2022-01-14 |
| K202783 | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing | Smith & Nephew Medical Limited | OMP | Class II | 2022-01-14 |
| K212318 | IPL Hair Removal | Dongguan Define Beauty Electronic Technology Co., Ltd. | OHT | Class II | 2022-01-14 |
| K212997 | Surgical Mask | Guangdong Zhizhen Biological Medical Co., Ltd. | FXX | Class II | 2022-01-14 |
| K212718 | Surgical gowns | Xiantao Dingcheng Non-Woven Product Co., Ltd. | FYA | Class II | 2022-01-12 |
| K213308 | Venus BlissMAX | Venus Concept USA, Inc. | PBX | Class II | 2022-01-12 |
| K212591 | Disposable Surgical Gown | Suzhou Janee Medical Technology Co., Ltd. | FYA | Class II | 2022-01-11 |
| K211260 | Sheng Jing Tang Surgical Mask | Liaoning Shengjingtang Biotechnology Co., Ltd. | FXX | Class II | 2022-01-10 |
| K212127 | Picocaremajesty | Wontech Co., Ltd. | GEX | Class II | 2022-01-07 |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | ONO | Class II | 2022-01-07 |
| K213841 | ENEO TOTALE (Model: ENEOT947) | Premier North America, Inc. | OHS | Class II | 2022-01-06 |
| K211149 | Urethral Warming Catheter Kit | Varian Medical Systems, Inc. | GEH | Class II | 2022-01-05 |
| K213344 | BTL-899A | BTL Industries, Inc. | GEI | Class II | 2022-01-05 |
| K211318 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs | Smith Nephew Medical Limited | OMP | Class II | 2022-01-05 |
| K212299 | Medical Surgical Mask | Wepon Medical Technology Co., Ltd. | FXX | Class II | 2022-01-04 |
| K212375 | Disposable Medical Surgical Mask | Jiangxi Bestgrand Health Technology Co., Ltd. | FXX | Class II | 2022-01-04 |
| K202994 | InnoClip Disposable Clip Applier, InnoClip Clip Applier | Taiwan Surgical Corporation | FZP | Class II | 2022-01-04 |
| K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle | Gyrus Acmi, Inc. | GEI | Class II | 2022-01-04 |
| K213068 | Medline Smoke Evacuation Shroud | Medline Industries, Inc. | FYD | Class II | 2022-01-03 |
| K202898 | Tzoar 207 Negative Pressure Wound Therapy (NPWT) System | Lightstone Medical Products (Ningbo) Co, Ltd. | OMP | Class II | 2021-12-30 |
| K211458 | Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers | Ningbo Verykind Medical Device Co., Ltd. | GDW | Class II | 2021-12-30 |
| K212848 | Sterile Latex Surgical Gloves Powder Free | Pentavest Holdings Sdn Bhd | KGO | Class I | 2021-12-27 |
| K213136 | CPL Surgical Face Mask | Control Print Limited | FXX | Class II | 2021-12-24 |
| K202255 | Skypro, SP02 Mask (3) | Skypro Medical Supplies Company | FXX | Class II | 2021-12-24 |
| K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | GAR | Class II | 2021-12-22 |
| K213225 | Diode Laser System GP900A8, Diode Laser System GP900Q8 | Shenzhen Gsd Tech Co., Ltd. | GEX | Class II | 2021-12-22 |
| K210147 | Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield | Unicoglobal, Inc. | FXX | Class II | 2021-12-22 |
| K213428 | EdgePro | Biolase, Inc. | NVK | Class II | 2021-12-22 |
| K213024 | Oren LED Perioral Light Therapy System | Shenzhen Kaiyan Medical CO , Ltd. | OHS | Class II | 2021-12-22 |
| K210968 | reVive Light Therapy Essentials | Led Technologies, Inc. | OLP | Class II | 2021-12-21 |
| K212155 | TheraFace LED | Theragun, Inc. | OHS | Class II | 2021-12-21 |
| K211521 | 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) | 3M Healthcare Business Group | OMP | Class II | 2021-12-20 |
| K211847 | AdVance XP Male Sling System | Boston Scientific Corporation | OTM | Class II | 2021-12-20 |
| K212492 | Frax 1940 for Nordlys and Frax Pro | Candela Corporation | GEX | Class II | 2021-12-20 |
| K211185 | IPL Home Use Hair Removal Device | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | OHT | Class II | 2021-12-20 |
| K211750 | Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) | National Bridge Industrial (S.Z.) Co., Ltd. | FXX | Class II | 2021-12-20 |
| K212059 | Surgical Face Mask | Zhongshan Saifute Labor Protective Articles Co., Ltd. | FXX | Class II | 2021-12-17 |
| K210102 | Topwide Surgical Face Mask | Topwide (Hubei) Medical Products Manufacturer | FXX | Class II | 2021-12-17 |
| K210077 | MED RF 4000 | F Care Systems USA, LLC | ONQ | Class II | 2021-12-17 |
| K210871 | PDO Max Suture with Dual Needle | Pdo Max, Inc. | NEW | Class II | 2021-12-17 |
| K203821 | Donagamex Blue Performance Protective Gown | Dong Nai Garment Corporation (Donagamex) | QPC | Class II | 2021-12-17 |
| K211172 | Single Use Electrosurgical Knife with Fluid Pump System | Micro-Tech (Nanjing) Co., Ltd. | GEI | Class II | 2021-12-17 |
| K210355 | Surgical Gown, Model: surgical gown-hp-3 | Weihai Dishang Medical Technology Co., Ltd. | FYA | Class II | 2021-12-16 |
| K211277 | Theia NPWT Foam Wound Dressing Kit | Clear Choice Therapeutics, Inc. | OMP | Class II | 2021-12-16 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.