Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 24
- Latest Decision
- 2021-05-20
Clearances · page 23 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K202899 | Procedure Mask, Surgical Mask | Kenpax International Limited | FXX | Class II | 2021-05-20 |
| K203415 | Surgical Isolation Gown | Yanbian Pacific Textile Co., Ltd. | FYC | Class II | 2021-05-20 |
| K202919 | ATS 5000 Automatic Tourniquet Instrument | Mcewen and Associates Consulting , Ltd. | KCY | Class I | 2021-05-20 |
| K202955 | Contour Light CL-100 | Contour Research, LLC | OLI | Class II | 2021-05-19 |
| K202709 | Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges | Ningbo Verykind Medical Device Co., Ltd. | GDW | Class II | 2021-05-18 |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | Olympus Winter & Ibe GmbH | GEI | Class II | 2021-05-17 |
| K211105 | Ear-Friendly Mask | Ray Co., Ltd. | FXX | Class II | 2021-05-17 |
| K210942 | MicroFrance Monopolar and Bipolar Electrosurgical Instruments | Integra Microfrance | GEI | Class II | 2021-05-14 |
| K210302 | Disposable Medical mask | Anhui Jbh Medical Apparatus Co., Ltd. | FXX | Class II | 2021-05-14 |
| K211130 | NPseal | Guard Medical, Inc. | OKO | Class II | 2021-05-14 |
| K202697 | United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask | United Sewing Automation, Inc. | FXX | Class II | 2021-05-13 |
| K210815 | Disposable Face Mask | Biobase Scientific (Shandong) Co., Ltd. | FXX | Class II | 2021-05-13 |
| K203481 | CryoVIVE | Recensmedical, Inc. | GEH | Class II | 2021-05-13 |
| K210168 | Diode Laser Therapy Systems | Beijing Kes Biology Technology Co., Ltd. | GEX | Class II | 2021-05-10 |
| K210218 | SURGICAL MASK, Model Name:C015 | Qingdao Hainuo Biological Engineering Co., Ltd. | FXX | Class II | 2021-05-07 |
| K210529 | Dr. Yglo Wart Remover | Theotclab Healthcare B.V. | GEH | Class II | 2021-05-06 |
| K203183 | CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) | Bolder Surgical, LLC | GEI | Class II | 2021-05-06 |
| K203640 | CoolSeal Reveal | Bolder Surgical, LLC | GEI | Class II | 2021-05-06 |
| K202598 | 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3 | 3A Medical Products Co., Ltd. | FXX | Class II | 2021-05-06 |
| K210705 | Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 | Defender Safety, Inc. | FXX | Class II | 2021-05-06 |
| K210304 | Surgical Mask | Jin Pin Electrical Co., Ltd. Zhuhai S.E.Z. | FXX | Class II | 2021-05-04 |
| K203135 | Medline Vacu-line Suction Aspirator | Medline Industries, Inc. | BTA | Class II | 2021-05-04 |
| K210675 | EasyWhip | Winter Innovations, Inc. | GAT | Class II | 2021-05-03 |
| K202430 | Kerecis Reconstruct | Kerecis Limited | OXH | Class II | 2021-05-02 |
| K203267 | The BioBrace Implant | Biorez, Inc. | OWW | Class II | 2021-04-30 |
| K203580 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | GEI | Class II | 2021-04-30 |
| K202457 | M1 Surgical Face Mask | CHISON Medical Technologies Co., Ltd. | FXX | Class II | 2021-04-29 |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | Olympus Winter & Ibe GmbH | GEI | Class II | 2021-04-28 |
| K210020 | Medical Mask | Zhende Medical Co., Ltd. | FXX | Class II | 2021-04-28 |
| K210278 | Titan SGS | Standard Bariatrics | GDW | Class II | 2021-04-28 |
| K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber | Boston Scientific | GEX | Class II | 2021-04-28 |
| K210964 | Resonic Rapid Acoustic Pulse Device | Soliton, Inc. | GEX | Class II | 2021-04-27 |
| K210663 | Dermatological Diode Laser Systems | Beijing HuaCheng Taike Technology Co., Ltd. | GEX | Class II | 2021-04-26 |
| K202258 | ERISE Laser handpiece | El.En Electronic Engineering Spa | GEX | Class II | 2021-04-26 |
| K193070 | VIVACE Electrosurgical Device | ShenB Co., Ltd. | GEI | Class II | 2021-04-26 |
| K202647 | Surgical Mask | Ningbo Green Textile Co., Ltd. | FXX | Class II | 2021-04-26 |
| K202257 | Dermatological Diode Laser Systems | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | GEX | Class II | 2021-04-23 |
| K202607 | Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs | String King Lacrosse, LLC | FXX | Class II | 2021-04-23 |
| K201853 | Naton Disposable Surgical Face Mask | Naton Biotechnology (Beijing) Co., Ltd. | FXX | Class II | 2021-04-23 |
| K202043 | Secret Duo | Ilooda Co,., Ltd. | GEX | Class II | 2021-04-23 |
| K202387 | Disposable Surgical Face Mask | Guangdong Bida Medical Technology Co., Ltd. | FXX | Class II | 2021-04-23 |
| K210030 | Medical Surgical Mask | Tianjin Aoshang Outdoor Equipment Co., Ltd. | FXX | Class II | 2021-04-23 |
| K210007 | Face Mask | Jinhua Jingdi Medical Supplies Co., Ltd. | FXX | Class II | 2021-04-23 |
| K203646 | Disposable Medical Face Mask | Guangzhou Mei YI Kang Medical Technology Co., Ltd. | FXX | Class II | 2021-04-22 |
| K202759 | Disposable medical surgical mask | Chongqing Coe Display Technology Co., Ltd. | FXX | Class II | 2021-04-21 |
| K210867 | NuEra Tight RF, NuEra Tight RF Plus | Bios S.R.L. | PBX | Class II | 2021-04-21 |
| K210600 | MOLLI | Molli Surgical, Inc. | NEU | Class II | 2021-04-16 |
| K202055 | Looper (Model: ZX-579S) | Heat IN A Click, LLC | OLP | Class II | 2021-04-16 |
| K201718 | GD Disposable Medical Face Mask | Jiangsu Guangda Medical Material Group Co., Ltd. | FXX | Class II | 2021-04-15 |
| K210338 | Edge Insulated Blade Electrode | Covidien, LLC | GEI | Class II | 2021-04-15 |
| K210752 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | NEU | Class II | 2021-04-14 |
| K201127 | DEFEND Ear-loop Face Masks | Young Dental Manufacturing Co. 1, LLC | FXX | Class II | 2021-04-14 |
| K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | ONG | Class II | 2021-04-13 |
| K210087 | Athena Surgical RMUS System | Athena Surgical, LLC | OTN | Class II | 2021-04-12 |
| K210018 | Disposable Medical Mask | Diasia Biomedical Technology Co., Ltd. | FXX | Class II | 2021-04-11 |
| K203012 | Surgical Mask | Customfab, Inc. | FXX | Class II | 2021-04-11 |
| K202761 | Medical Surgical Mask (Non-sterile) | Guangdong Goodfeeling Hygiene Material Tec Co., Ltd. | FXX | Class II | 2021-04-11 |
| K202513 | Disposable Medical Face Mask-Model FM-04 | Shenzhen Jinko Industrial Co., Ltd. | FXX | Class II | 2021-04-09 |
| K210062 | Mectaplug PE II | Medacta International S.A. | JDK | Class II | 2021-04-08 |
| K203491 | PicoLO Nd: YAG Picosecond Laser System | Laseroptek Co., Ltd. | GEX | Class II | 2021-04-07 |
| K203801 | Disposable Surgical Face Mask | Anhui Jiabao Protective Equipments Co., Ltd. | FXX | Class II | 2021-04-06 |
| K202655 | Disposable Medical Mask | Dongguan Runlin Medical Supplies Technology Co., Ltd. | FXX | Class II | 2021-04-05 |
| K202447 | Medline Orbis Surgical Gown | Medline Industries, Inc. | FYA | Class II | 2021-04-02 |
| K201171 | LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable | Leoni Fiber Optics, Inc. | GEX | Class II | 2021-04-02 |
| K202243 | SkinPen Precision System | Crown Aesthetics | QAI | Class II | 2021-04-02 |
| K210023 | Surgical Face Mask | Guangdong Winsun Personal Care Products Co.,Ltd | FXX | Class II | 2021-04-02 |
| K203795 | Star RF Electrode, VIVA RF Electrode | Starmed Co., Ltd. | GEI | Class II | 2021-04-01 |
| K203101 | Secure Wear USA Surgical Face Mask | Secured Ortho Manufacturing of America, LLC | FXX | Class II | 2021-03-31 |
| K202424 | Surgical Mask-Models CR02-2, CR02 | Foshan Xinbao Technology Co., Ltd. | FXX | Class II | 2021-03-31 |
| K210226 | PicoSure Workstation | Cynosure, LLC | GEX | Class II | 2021-03-30 |
| K201896 | ivi N3003 Surgical face Mask, ivi N6006 Surgical mask | Iob Medical, Inc. | FXX | Class II | 2021-03-30 |
| K202708 | Surgical Face Masks | Intco Medical(Hk) Co., Ltd. | FXX | Class II | 2021-03-30 |
| K202191 | Surgical Mask | Wuhan Zonsen Medical Products Co., Ltd. | FXX | Class II | 2021-03-29 |
| K201466 | Tranberg CLS Laser Applicator | Clinical Laserthermia Systems, AB | GEX | Class II | 2021-03-26 |
| K202905 | Disposable Face Mask | Jiangsu Excellence Medical Supplies Co., Ltd. | FXX | Class II | 2021-03-26 |
| K203685 | Disposable Surgical Face Mask | Xiantao Zhongyi Safety & Protection Products Co., Ltd. | FXX | Class II | 2021-03-26 |
| K203788 | DermaV Laser System | Lutronic Corporation | GEX | Class II | 2021-03-26 |
| K202133 | Disposable Medical Mask | Hangzhou Qianzhiya Sanitary Products Co., Ltd. | FXX | Class II | 2021-03-25 |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | Northgate Technologies, Inc. | FYD | Class II | 2021-03-25 |
| K202824 | BRS Procedure Face Mask | Blackbriar Regulatory Services, LLC | FXX | Class II | 2021-03-25 |
| K203776 | Surgical Masks, Model SNN200640 & MN112 | Sq Medical Supplies, Inc. | FXX | Class II | 2021-03-25 |
| K202650 | Medical disposable face mask non sterile | Guangdong Zhong Ling Industrial Group Co., Ltd. | FXX | Class II | 2021-03-24 |
| K203064 | ICU Health Surgical Mask | Plastikon Industries | FXX | Class II | 2021-03-23 |
| K202917 | LigaSure Exact Dissector, Nano-coated | Covidien, LLC | GEI | Class II | 2021-03-23 |
| K202628 | Disposable Medical Face Mask | Qinghai Zhong Dao Win-Win Medical Protective Equipment Co., | FXX | Class II | 2021-03-19 |
| K202985 | LightWalker Laser System Family | Fotona D.O.O. | GEX | Class II | 2021-03-19 |
| K201095 | Sovereign America Surgical Face Mask | Homtex, Inc. | FXX | Class II | 2021-03-19 |
| K201624 | Spin Care Disposable Protective Mask | Spintech, LLC | FXX | Class II | 2021-03-18 |
| K203186 | DYNATAPE Suture | Medos International SARL | GAT | Class II | 2021-03-18 |
| K210487 | MIPLNI YK-244 Disposable Surgical Mask | Hunan Yuankang Biological Technology Co., Ltd. | FXX | Class II | 2021-03-16 |
| K201924 | Single-Use Surgical Mask | Qiqihar Hengxin Medical Supplies, Ltd. | FXX | Class II | 2021-03-15 |
| K201698 | Medical Surgical Mask | Hangzhou Mycode Bio-Medicine Co., Ltd. | FXX | Class II | 2021-03-15 |
| K210526 | Medline Cautery Tip Cleaner | Medline Industries, Inc. | GEI | Class II | 2021-03-12 |
| K203775 | AIC disposable medical mask | The Aleen International Corporation | FXX | Class II | 2021-03-12 |
| K210142 | Fiber Dust | Quanta System Spa | GEX | Class II | 2021-03-11 |
| K202443 | Smart Kit Basic, Smart Kit Pro | Bsl Co., Ltd. | MUU | Class II | 2021-03-11 |
| K202961 | AquaBeam Robotic System | Procept Biorobotics, Corporation | PZP | Class II | 2021-03-11 |
| K202411 | Surgical Mask | Allmed Medical Products Co., Ltd. | FXX | Class II | 2021-03-10 |
| K202161 | Surgical Face Mask | Hunan Eexi Technology & Service Co., Ltd. | FXX | Class II | 2021-03-10 |
| K202548 | Surgical Face Mask | Wanxinda (Guangzhou) Technology Product Co., Ltd. | FXX | Class II | 2021-03-10 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.