Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 28
- Latest Decision
- 2021-07-30
Clearances · page 22 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K202780 | Sectum | Neauvia North America | PBX | Class II | 2021-07-30 |
| K211761 | UltraLase Flexible CO2 Laser Waveguide | W & R Investments, LLC Dba Laser Engineering | GEX | Class II | 2021-07-30 |
| K211402 | Powersculp laser lipolysis system | Lotuxs Medtech (Suzhou) Co., Ltd. | PKT | Class II | 2021-07-30 |
| K211994 | Braun Silk.expert Mini | Cyden Limited | OHT | Class II | 2021-07-28 |
| K211861 | TAIJI Professional Series Level 3 Surgical Face Mask | Taiji Medical Supplies, Inc. | FXX | Class II | 2021-07-28 |
| K210409 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co., Ltd. | FXX | Class II | 2021-07-28 |
| K210856 | Purism Disposable Surgical Mask | Chuzhou Daddy'S Choice Science and Technology Co., Ltd. | FXX | Class II | 2021-07-28 |
| K211497 | Surgical Mask | Honeywell Safety Products | FXX | Class II | 2021-07-28 |
| K211335 | Diode Laser Machine, Model Number: BM-100 | Zhengzhou Bestview ST Co., Ltd. | GEX | Class II | 2021-07-28 |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | AtriCure, Inc. | OCL | Class II | 2021-07-26 |
| K211984 | MASC Surgical Mask | Mid-America Safety Corp. | FXX | Class II | 2021-07-25 |
| K211363 | Medical Face Mask | Hubei Kangning Protective Products Co., Ltd. | FXX | Class II | 2021-07-24 |
| K211249 | Altor Safety 3-Ply Surgical Mask (Model:62222) | Altor Safety, LLC | FXX | Class II | 2021-07-23 |
| K201265 | Disposable Microwave Therapeutic Antennas | Nanjing Eco Microwave System Co., Ltd. | NEY | Class II | 2021-07-23 |
| K210311 | Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. | Shenzhen Mismon Technology Co., Ltd. | OHT | Class II | 2021-07-23 |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | ESW | Class II | 2021-07-23 |
| K210143 | Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) | Foshan Nanhai Plus Medical Co, Ltd. | FYA | Class II | 2021-07-22 |
| K203214 | DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO , Ltd. | OLP | Class II | 2021-07-22 |
| K210391 | Single-use medical face mask | Zhuhai Herald Datanetics Limited. | FXX | Class II | 2021-07-22 |
| K203534 | Surgical face mask (Model: Flat Ear Loop/CN102) | Crown Name Disposable Hygiene Products Fty., Ltd. | FXX | Class II | 2021-07-21 |
| K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | OTN | Class II | 2021-07-21 |
| K211901 | MolecuLightDX | MolecuLight, Inc. | QJF | Class II | 2021-07-21 |
| K203271 | Aduro light therapy Handheld | Shenzhen Kaiyan Medical CO , Ltd. | OLP | Class II | 2021-07-21 |
| K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown | O&M Halyard, Inc. | FYA | Class II | 2021-07-21 |
| K210970 | Single-Use Surgical Mask Model FE2311B | Byd Precison Manufacturer Co., Ltd. | FXX | Class II | 2021-07-21 |
| K210129 | RF Thermal System | Luvo Medical Technologies, Inc. | PBX | Class II | 2021-07-20 |
| K210877 | Evolve System with the T3 Applicator | InMode , Ltd. | PBX | Class II | 2021-07-19 |
| K211946 | Soniquence Reusable Bipolar Cable | Soniquence, LLC | GEI | Class II | 2021-07-16 |
| K211792 | StitchKit | Origami Surgical Inc . | GAM | Class II | 2021-07-16 |
| K210761 | Velguard Surgical Face Mask | Esstee Exports Health Care Division | FXX | Class II | 2021-07-16 |
| K211042 | Disposable Procedural Ear-loop Face Mask | Changzhou Dsb Medical Co., Ltd. | FXX | Class II | 2021-07-15 |
| K211514 | Longeviti PorousFit implant | Longeviti Neuro Solutions, LLC | KKY | Class II | 2021-07-15 |
| K201844 | Surgical Face Mask, Surgical Mask | Lear Corporation | FXX | Class II | 2021-07-14 |
| K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine | Ningbo Hesi Electric Co., Ltd. | OHS | Class II | 2021-07-14 |
| K203728 | Darwin | Luvo Medical Technologies, Inc. | GEX | Class II | 2021-07-14 |
| K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO , Ltd. | OHS | Class II | 2021-07-14 |
| K203496 | Nexo-Gide Bilayer Collagen Membrane | Geistlich Pharma AG | FTM | Class II | 2021-07-14 |
| K210244 | Disposable Medical Face Mask | Suzhou Bolisi Medical Technology Co., Ltd. | FXX | Class II | 2021-07-12 |
| K210492 | InMode RF Pro System | Inmode MD , Ltd. | GEI | Class II | 2021-07-12 |
| K200915 | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs | Gx Corporation Sdn Bhd | KGO | Class I | 2021-07-09 |
| K211107 | BTL-899 FP | BTL Industries, Inc. | GEI | Class II | 2021-07-09 |
| K202517 | Cytrellis Dermal Micro-Coring System | Cytrellis Biosystems, Inc. | QAI | Class II | 2021-07-09 |
| K201262 | Microwave Therapeutic System | Nanjing Eco Microwave System Co., Ltd. | NEY | Class II | 2021-07-09 |
| K210380 | Medical surgical mask | Shantou T&K Medical Equipment Factory Co.,Ltd | FXX | Class II | 2021-07-08 |
| K210267 | Disposable Surgical Mask | Xiamen Eagledon Pharmaceutical Co., Ltd. | FXX | Class II | 2021-07-08 |
| K210524 | Surgical Mask | Changzhou Holymed Products Co., Ltd. | FXX | Class II | 2021-07-07 |
| K210215 | Surgical Gowns | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | FYA | Class II | 2021-07-07 |
| K201740 | Hydrozid | Medilink A/S | GEH | Class II | 2021-07-07 |
| K211821 | DEKA Motus AZ | El.En Electronic Engineering Spa | GEX | Class II | 2021-07-06 |
| K203591 | Single-use Medical Face Mask | Conod Medical Co., Limited | FXX | Class II | 2021-07-02 |
| K203441 | The Alma Hybrid Laser System | Alma Lasers , Ltd. | GEX | Class II | 2021-07-02 |
| K203800 | SyntrFuge System | Syntr Health Technologies, Inc. | MUU | Class II | 2021-07-02 |
| K202954 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co., Ltd. | FXX | Class II | 2021-07-02 |
| K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | FYA | Class II | 2021-07-02 |
| K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) System | Molnlycke Health Care Us, LLC | OMP | Class II | 2021-07-01 |
| K210445 | Nordiwell Surprotect Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | FXX | Class II | 2021-06-29 |
| K210954 | Synergy | Yrs Group, Inc. | OHS | Class II | 2021-06-29 |
| K210098 | PuraStat-GI | 3-D Matrix, Inc. | QAU | Class II | 2021-06-25 |
| K210948 | Omnilux CLEAR | Globalmed Technologies | OLP | Class II | 2021-06-24 |
| K210656 | ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | Careplus (M) Sdn Bhd | KGO | Class I | 2021-06-24 |
| K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | ArthroCare Corporation | GEI | Class II | 2021-06-24 |
| K210909 | easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use | Ezisurg Medical Co., Ltd. | GDW | Class II | 2021-06-24 |
| K210882 | MolecuLight I:X | MolecuLight, Inc. | QJF | Class II | 2021-06-22 |
| K210840 | Disposable Surgical Mask | Safeway Industry Healthcare. | FXX | Class II | 2021-06-22 |
| K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | I-Tech Industries Srl | NUV | Class II | 2021-06-22 |
| K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | FTC | Class II | 2021-06-22 |
| K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | GEX | Class II | 2021-06-22 |
| K203200 | Disposable Medical Surgical Face Mask | Guangdong Haiou Medical Apparatus Co., Ltd. | FXX | Class II | 2021-06-16 |
| K211520 | Amerishield Surgical Mask | Premiumestore, LLC | FXX | Class II | 2021-06-15 |
| K210518 | Surgical Face Mask | Shandong Haidike Medical Products Co., Ltd. | FXX | Class II | 2021-06-14 |
| K203732 | Surgical Face Mask | Zhuhai Gaoge Medical Technology Co., Ltd. | FXX | Class II | 2021-06-11 |
| K202714 | Medical Face Mask | Chongqing Chaoke Industry Development Co., Ltd. | FXX | Class II | 2021-06-11 |
| K203030 | POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Wrp Asia Pacific Sdn. Bhd. | KGO | Class I | 2021-06-11 |
| K210767 | Surgical Masks, Model:FE-1 | Hunan Triplex Precision Medical Devices Co., Ltd. | FXX | Class II | 2021-06-10 |
| K210015 | Surgical Face Mask | Sample King Manufacturing, Ltd. | FXX | Class II | 2021-06-10 |
| K203756 | Disposable Surgical Mask | Lucky Textile Industrial(Wuxi) Co., Ltd. | FXX | Class II | 2021-06-10 |
| K202126 | Disposable Surgical Mask | Shenzhen Peninsula Medical Co., Ltd. | FXX | Class II | 2021-06-08 |
| K211062 | Medical Face Mask | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | FXX | Class II | 2021-06-08 |
| K210641 | Disposable Medical Mask | Tuosheng Protective Products (Ningbo) Co., Ltd. | FXX | Class II | 2021-06-07 |
| K202580 | Disposable Surgical Mask | Qingdao Likangyuan Medical Device Co., Ltd. | FXX | Class II | 2021-06-07 |
| K210372 | Disposable Surgical Mask | Dongguan Shin YI Healthcare Products Factory | FXX | Class II | 2021-06-07 |
| K210433 | Surgical Face Mask (Ear loops and Tie-on) | Wuhan Dymex Healthcare Co., Ltd. | FXX | Class II | 2021-06-07 |
| K203388 | Disposable medical mask | Everwin Toys (Dongguan)., Ltd. | FXX | Class II | 2021-06-04 |
| K202828 | Surgical Green Laser System | Realton (Suzhou) Medical Technology Co., Ltd. | GEX | Class II | 2021-06-04 |
| K202217 | Kendall NPWT Incision Management Device | Cardinalhealth | OMP | Class II | 2021-06-04 |
| K203704 | Surgical face mask | Juntech(Jiaxing)Healthcare Materials Co,.Ltd | FXX | Class II | 2021-06-04 |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Gyrus Acmi, Inc. | GEX | Class II | 2021-06-03 |
| K202128 | Allmed Surgical Face Masks (Ear loops) | Allmed Medical Products Co., Ltd. | FXX | Class II | 2021-06-03 |
| K210150 | Disposable Medical mask | Hubei Wanli Protective Products Co., Ltd. | FXX | Class II | 2021-06-02 |
| K210429 | Disposable Surgical Face Mask | Jiangxi Heying Pharmaceutical Co., Ltd. | FXX | Class II | 2021-06-02 |
| K203190 | Surgical Face Mask | Rfx+Care Manufactoring Co., Ltd. | FXX | Class II | 2021-06-02 |
| K211440 | ASM-301 Level 3 Surgical Mask | American Surgical Mask Company, LLC | FXX | Class II | 2021-06-02 |
| K211311 | AtriCure Isolator® Synergy Surgical Ablation System | AtriCure, Inc. | OCL | Class II | 2021-05-28 |
| K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs | Careplus (M) Sdn Bhd | KGO | Class I | 2021-05-27 |
| K201639 | Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | GDW | Class II | 2021-05-27 |
| K211307 | GalaSTITCH Absorbable Monofilament Suture | Tepha, Inc. | NWJ | Class II | 2021-05-27 |
| K203144 | MicroPen EVO | Eclipse Medcorp, LLC | QAI | Class II | 2021-05-25 |
| K211275 | AirMax Procedure Mask | Premiumestore, LLC | FXX | Class II | 2021-05-25 |
| K210535 | UltraLight LED System | Rohrer Aesthetics, LLC | GEX | Class II | 2021-05-24 |
| K210119 | IPL Hair Removal Device (Model: KCA423) | Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. | ONF | Class II | 2021-05-21 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.