Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 30
- Latest Decision
- 2021-12-16
Clearances · page 20 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K211378 | LM Surgical Mask Level 3, LM Surgical Mask Level 2, | Liberty Mask, LLC | FXX | Class II | 2021-12-16 |
| K213020 | IPL hair removal machine | Shenzhen Borria Technology Co., Ltd. | OHT | Class II | 2021-12-16 |
| K211217 | Profound Matrix | Candela Corporation | GEI | Class II | 2021-12-16 |
| K202818 | Voyant Fine Fusion Device (EB230) | Applied Medical | GEI | Class II | 2021-12-16 |
| K210405 | ProTEC-USA EZDoff Gown | Cadillac Products, Inc. | QPC | Class II | 2021-12-15 |
| K212944 | Disposable Surgical Mask | Heilongjiang Yinjia Medical Equipment Co., Ltd. | FXX | Class II | 2021-12-15 |
| K212398 | Surgical Face Mask (Non-sterile) | Hubei Kimsoul Industrial Co., Ltd. | FXX | Class II | 2021-12-15 |
| K202823 | Innomed NPWT Silicone Foam Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | OMP | Class II | 2021-12-15 |
| K212861 | Surgical Gown, Reinforced Surgical Gown | Wuhan Zonsen Medical Products Co., Ltd. | FYA | Class II | 2021-12-15 |
| K210965 | reVive Light Therapy Essentials | Led Technologies, Inc. | OHS | Class II | 2021-12-15 |
| K203716 | PICO Single Use Negative Pressure Wound Therapy System, 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 | Smith and Nephew Medical Limited | QFC | Class II | 2021-12-14 |
| K202848 | S2 Pigment Removal System | Lightsense Technologies, Ltd. | GEX | Class II | 2021-12-14 |
| K212574 | Surgical Face Mask | Xiantao Deming Healthcare Products Co., Ltd. | FXX | Class II | 2021-12-14 |
| K210744 | Surgical Mask | Chongqing PA Xijia Biotechnology Co., Ltd. | FXX | Class II | 2021-12-14 |
| K212869 | Disposable Surgical Gown, Disposable Reinforced Surgical Gown | Fugou County Shenxiang Manufacturing Co., Ltd. | FYA | Class II | 2021-12-13 |
| K202794 | Surgical face mask: F-Y1-A | Jiande Chaomei Daily Chemicals Co., Ltd. | FXX | Class II | 2021-12-13 |
| K212925 | Disposable Surgical Gown | Henan Robestain Medical Products Co., Ltd. | FYA | Class II | 2021-12-13 |
| K212867 | Medical Surgical Mask | Nanchang Kanghua Health Materials Co., Ltd. | FXX | Class II | 2021-12-11 |
| K210004 | i8 Tanning Booth | Ultrasun International B.V. | FTC | Class II | 2021-12-10 |
| K210847 | UltraClear Fractional Laser System | Fa International, LP | GEX | Class II | 2021-12-10 |
| K203539 | Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) | Unicoglobal, Inc. | FYA | Class II | 2021-12-10 |
| K212329 | Plasma IQ | Neauvia North America, Inc. | GEI | Class II | 2021-12-09 |
| K212573 | PicoLO Premium | Laseroptek Co., Ltd. | GEX | Class II | 2021-12-08 |
| K211487 | MAF Guard | Maf Clothing Pvt Ltd Unit-3 | FXX | Class II | 2021-12-08 |
| K212302 | BAYLAB 3-Ply Surgical Mask (BEACON I) | Baylab USA, LLC | FXX | Class II | 2021-12-07 |
| K213512 | DERMABOND PRINEO Skin Closure System | ETHICON, Inc. | OMD | Class II | 2021-12-07 |
| K211772 | PMW01 Procedure Mask Level 1 | Defender Safety, Inc. | FXX | Class II | 2021-12-06 |
| K212235 | Surgical Face Mask | Shanghai Yunqing Industrial Co., Ltd. | FXX | Class II | 2021-12-06 |
| K212807 | Surgical Masks | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | FXX | Class II | 2021-12-03 |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | NEY | Class II | 2021-12-03 |
| K212258 | Medline Cardiovascular Procedure Kit | Medline Industries, Inc. | LRO | Class II | 2021-12-03 |
| DEN200005 | Klox Biophotonic LumiHeal System | Klox Technlogies, Inc. | QPE | Class II | 2021-12-03 |
| K203745 | AURORA Evacuator +Coag | Rebound Therapeutics | GEI | Class II | 2021-12-02 |
| K212740 | Puravita Medical Fold Flat Surgical Mask | Puravita M, LLC | FXX | Class II | 2021-12-02 |
| K202175 | OxyLight 2.0 | Raja Trading Company, Inc. | GEX | Class II | 2021-12-02 |
| K211773 | Single-use Surgical Mask | Taiwan Seafood and Fish Corporation | FXX | Class II | 2021-12-02 |
| K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products , Ltd. | ONF | Class II | 2021-12-02 |
| K211696 | Disposable Surgical Face Mask | Anhui Cleanpro Pharmpack Co., Ltd. | FXX | Class II | 2021-11-30 |
| K212814 | C2 CryoBalloon Ablation System | Pentax of America, Inc. | GEH | Class II | 2021-11-29 |
| K202842 | Medical surgical mask | Henan Huibo Medical Co., Ltd. | FXX | Class II | 2021-11-26 |
| K211295 | Surgical Mask (sterile) | Nanjing 3h Medical Products Co., Ltd. | FXX | Class II | 2021-11-24 |
| K212558 | MicroPen EVO | Eclipse Medcorp, LLC | QAI | Class II | 2021-11-24 |
| K212633 | Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue | String King Lacrosse, LLC | FYC | Class II | 2021-11-24 |
| K211956 | 039 Surgical Face Mask | Aok Tooling Limited | FXX | Class II | 2021-11-23 |
| K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown | Cardinal Health, LLC | FYA | Class II | 2021-11-23 |
| K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | OLP | Class II | 2021-11-23 |
| K211562 | Virtue RF | ShenB Co., Ltd. | GEI | Class II | 2021-11-23 |
| K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | ESW | Class II | 2021-11-22 |
| K212697 | Leaf Smooth | Shenzhen Leaflife Technology Co., Ltd. | OHT | Class II | 2021-11-19 |
| K202288 | Finebeam | SNJ Co., Ltd. | GEX | Class II | 2021-11-19 |
| K212046 | Impertech Surgical Face Mask | Impertech Industries , Ltd. | FXX | Class II | 2021-11-18 |
| K213406 | Savvy Mask - Level 3 Surgical Face Mask | Texas Medplast, LLC | FXX | Class II | 2021-11-18 |
| K212275 | Dermalux Flex MD | Aesthetic Technology, Ltd. | OHS | Class II | 2021-11-18 |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | ESW | Class II | 2021-11-18 |
| K210350 | Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC | NVK | Class II | 2021-11-18 |
| K213041 | IPL Hair Removal, Model: OBT-02 | Glan Electronics Co., Ltd. | OHT | Class II | 2021-11-18 |
| K211538 | Protect X Level 3 Isolation Gown | Azac Group | FYC | Class II | 2021-11-17 |
| K210042 | Disposable Surgical Mask | Suzhou Letian Protective Products Co., Ltd. | FXX | Class II | 2021-11-17 |
| K212344 | Surgical Mask | Xiantao Dingcheng Non-Woven Product Co., Ltd. | FXX | Class II | 2021-11-16 |
| K212607 | Darwin | Luvo Medical Technologies, Inc. | GEX | Class II | 2021-11-15 |
| K211483 | SofWave System | Sofwave Medical, Ltd. | OHV | Class II | 2021-11-15 |
| K212575 | Surgical Face Mask | Hubei Huanfu Plastic Products Co., Ltd. | FXX | Class II | 2021-11-14 |
| K212109 | Spin Care Disposable Protective Mask Level 3 | Spintech, LLC | FXX | Class II | 2021-11-14 |
| K210785 | Disposable Surgical Gowns | Chongqing Litai Fashion Group Limited Company | FYC | Class II | 2021-11-13 |
| K212264 | Surgical Face mask | Nantong Taiweishi Medical Technology Co., Ltd. | FXX | Class II | 2021-11-13 |
| K212978 | Diode laser therapy system | Beijing Unt Technology Co., Ltd. | GEX | Class II | 2021-11-10 |
| K212107 | Reverso | Intelis Instruments , Ltd. | GEI | Class II | 2021-11-10 |
| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | Caldera Medical, Inc. | OTN | Class II | 2021-11-10 |
| K212331 | BodySculp | Rohrer Aesthetics, LLC | PKT | Class II | 2021-11-09 |
| K211165 | Medical Face Masks, Model Name:MY020003 | Huizhou Jie Bai Purification Co., Ltd. | FXX | Class II | 2021-11-09 |
| K211517 | Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories | Convergent Laser Technologies | GEX | Class II | 2021-11-09 |
| K212526 | Surgical Face Mask | Suzhou Janee Medical Technology Co., Ltd. | FXX | Class II | 2021-11-09 |
| K212504 | Isolation Gown AAMI Level 3 | Kenpax International Limited | FYC | Class II | 2021-11-07 |
| K212707 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. | OOK | Class II | 2021-11-05 |
| K212502 | Resonic Rapid Acoustic Pulse Device | Soliton, Inc. | GEX | Class II | 2021-11-05 |
| K202676 | Disposable Medical Face Mask | Zhejiang Senhong Medical&Instrument Co., Ltd. | FXX | Class II | 2021-11-05 |
| K212460 | Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) | Guangzhou Zhengkang Medical Equipment Co.,Ltd | FXX | Class II | 2021-11-05 |
| K212897 | IPL Hair Removal Device, model: AI01 | Shenzhen Century Dongyuan Technology CO , Ltd. | OHT | Class II | 2021-11-04 |
| K212471 | Medical Face Mask | Haian Medigauze Co., Ltd. | FXX | Class II | 2021-11-04 |
| K212510 | 7 Series Phototherapy Device | Daavlin Distributing Co. | FTC | Class II | 2021-11-04 |
| K210969 | Nulife | Mrk Healthcare Pvt, Ltd. | KGO | Class I | 2021-11-03 |
| K210222 | Disposable Medical Mask | Guangdong Lide Medical Technology Co., Ltd. | FXX | Class II | 2021-11-02 |
| K212306 | Tapestry Biointegrative Implant | Embody, Inc. | OWY | Class II | 2021-11-02 |
| K212403 | Tracheal Stent System (Y-Shaped) | Micro-Tech (Nanjing) Co., Ltd. | JCT | Class II | 2021-10-30 |
| K213163 | VersaWrap | Alafair Biosciences, Inc. | FTM | Class II | 2021-10-29 |
| K211019 | Disposable Monopolar Laparoscopic Tips and Reusable Handles | Dannik, LLC | GEI | Class II | 2021-10-28 |
| K203316 | V.A.C.ULTA Negative Pressure Wound Therapy System | Kci, A Part of 3M Health Care Business Group | OMP | Class II | 2021-10-27 |
| K201520 | The Alma Opus System, Colibri Applicator and Tips | Alma Lasers, Inc. | GEI | Class II | 2021-10-27 |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | FTM | Class II | 2021-10-27 |
| K211977 | Medical Diode Laser Systems | Wuhan Dimed Laser Technology Co., Ltd. | GEX | Class II | 2021-10-26 |
| K202998 | Vydence Zye and Vydence One | Vydence Medical Industria E Comercio Ltda | GEX | Class II | 2021-10-26 |
| K210488 | Ultrasonic Surgical & Electrosurgical Generator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | GEI | Class II | 2021-10-25 |
| K213386 | Titan Manufacturing Bipolar Forceps | Titan Manufacturing, Inc. | GEI | Class II | 2021-10-25 |
| K212793 | Laser Treatment System, Model: Hera, Armo | Canadian Pioneer Medical Technology Corporation | GEX | Class II | 2021-10-25 |
| K212293 | Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) | Jiangmen Ningrui Medical Supplies Co., Ltd. | FXX | Class II | 2021-10-25 |
| K212146 | Arthrex LoopLoc Knotless Suture | Arthrex, Inc. | GAT | Class II | 2021-10-25 |
| K212368 | Surgical Face Mask | Anhui Tiankang Medical Technology Co., Ltd. | FXX | Class II | 2021-10-24 |
| K210348 | Disposable Medical Surgical Mask | Weihai Dishang Medical Technology Co., Ltd. | FXX | Class II | 2021-10-24 |
| K211509 | Surgical Gown | Hubei Wanli Protective Products Co., Ltd. | FYA | Class II | 2021-10-24 |
| K211735 | CO2 Laser Machine, Model: BW-203B | Zhengzhou Bestview ST Co., Ltd. | GEX | Class II | 2021-10-22 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.