Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 29
- Latest Decision
- 2021-10-22
Clearances · page 21 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K212399 | Aveli | Nc8, Inc. | OUP | Class II | 2021-10-22 |
| K210310 | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit | Nuance Medical, LLC | GEH | Class II | 2021-10-22 |
| K212666 | Neuromark System | Neurent Medical | GEI | Class II | 2021-10-22 |
| K212270 | DEKA LipoAI | El.En Electronic Engineering Spa | GEX | Class II | 2021-10-21 |
| K212314 | IPL Hair Removal Device | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | OHT | Class II | 2021-10-21 |
| K211526 | Portable Scalp Cooling System | Cooler Heads Care, Inc. | PMC | Class II | 2021-10-21 |
| K211170 | Single Use Irrigation bipolar cable | Modern Medical Equipment Manufacturing, Ltd. | GEI | Class II | 2021-10-19 |
| K201773 | PICOHI | Hironic Co., Ltd. | GEX | Class II | 2021-10-19 |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | Lumenis, Ltd. | GEX | Class II | 2021-10-19 |
| K203565 | Surgical 3D Mask | Inno Lifecare | FXX | Class II | 2021-10-19 |
| K211809 | Surgical Gown | Wuhan Dymex Healthcare Co., Ltd. | FYA | Class II | 2021-10-18 |
| K211091 | Deka Tiac II | El.En Electronic Engineering Spa | PBX | Class II | 2021-10-15 |
| K211461 | Family of Venus RF Systems - Venus Freedom | Venus Concept USA, Inc. | PBX | Class II | 2021-10-14 |
| K212205 | Medical Protective Masks | Qinhuangdao Taizhi Medical Technology Co., Ltd. | FXX | Class II | 2021-10-14 |
| K210845 | Disposable Surgical Mask (Model: YYKZ-01) | Jiaxing Amazing Travel-Ware Co., Ltd. | FXX | Class II | 2021-10-12 |
| K201514 | Child Face Mask | Shandong Shengquan New Material Co., Ltd. | OXZ | Class II | 2021-10-10 |
| K210813 | Medical Surgical Mask | Sichuan Pharmaceutical., Inc. | FXX | Class II | 2021-10-08 |
| K210622 | Single-Use Medical Face Mask | Jiangxi Hongda Medical Equipment Group Co., Ltd. | FXX | Class II | 2021-10-08 |
| K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | ESW | Class II | 2021-10-08 |
| K210376 | Superior Hair Remover | Guangzhou Haoxingwan Technology Co., Ltd. | OHT | Class II | 2021-10-07 |
| K211077 | Surgical Gown | Wujiang Tutaike Textiles & Finishing Co., Ltd. | FYA | Class II | 2021-10-07 |
| K212835 | AquaBeam Robotic System | Procept Biorobotics, Corporation | PZP | Class II | 2021-10-06 |
| K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) | Careplus (M) Sdn Bhd | KGO | Class I | 2021-10-06 |
| K212082 | Picore | Bio-Med USA, Inc. | GEX | Class II | 2021-10-06 |
| K211899 | Surgical Face Mask | Hubei Yi-Ya Protective Products Co., Ltd. | FXX | Class II | 2021-10-04 |
| K211425 | Private Stock Labs Surgical Face Mask | J.K. Private Stock, Inc. | FXX | Class II | 2021-10-04 |
| K211368 | IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. | ONF | Class II | 2021-10-04 |
| K201934 | Surgimatix Absorbable Fixation System | Surgimatix, Inc. | GDW | Class II | 2021-10-01 |
| K210513 | UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 | Universal Incorporation | FXX | Class II | 2021-09-29 |
| K200639 | LAP-iX | Sejong Medical Co., Ltd. | GEI | Class II | 2021-09-29 |
| K212045 | SoftSpot | Pediametrix, Inc. | QQO | Class I | 2021-09-28 |
| K211794 | Disposable surgical mask | Shanghai No.9 Knitting Mill Co., Ltd. | FXX | Class II | 2021-09-28 |
| K210878 | Surgical Face Mask (Model: CM2006, CM2008, A88) | Shenzhen Realtone Medical Appliance Co., Ltd. | FXX | Class II | 2021-09-28 |
| K212320 | Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac | 3M Healthcare Business Group | OMP | Class II | 2021-09-28 |
| K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action | Olympus Surgical Technologies America | GEI | Class II | 2021-09-27 |
| K210908 | Surgical Mask | Sichuan Prius Biotechnology Co., Ltd. | FXX | Class II | 2021-09-26 |
| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove | Cardinal Health200, LLC | KGO | Class I | 2021-09-26 |
| K212099 | Red Wave Hair Removal | Shenzhen Accompany Technology Co., Ltd. | ONF | Class II | 2021-09-24 |
| K211827 | Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) | Zhejiang Lanhine Medical Products, Ltd. | FXX | Class II | 2021-09-23 |
| K211097 | Banyan USA Surgical Mask Level 3 | Banyan USA, LLC | FXX | Class II | 2021-09-22 |
| K210772 | 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) | Vr Vertical, LLC Dba Xrgo | FXX | Class II | 2021-09-22 |
| K211922 | IPL Home Use Hair Removal Device | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | OHT | Class II | 2021-09-20 |
| K203799 | ProFlex CO2 Laser Fiber | Innovaquartz, LLC | GEX | Class II | 2021-09-20 |
| K211751 | WELLTRUST WT-III Mask with Flat Earloop | Lonestar Meadows, LLC | FXX | Class II | 2021-09-17 |
| K203418 | Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) | Ningbo Ouhan Medical Device Co., Ltd. | FXX | Class II | 2021-09-17 |
| K203112 | Disposable Medical Mask | Yangzhou Runyi Arts & Crafts Co., Ltd. | FXX | Class II | 2021-09-16 |
| K211478 | Sterile Latex Surgical Gloves Powder Free | Aspen Glove Sdn. Bhd. | KGO | Class I | 2021-09-16 |
| K210184 | Wilson Tech Disposable Medical Face Mask | Wilson Tech (International) Limited | FXX | Class II | 2021-09-14 |
| K212678 | Viveve System, Viveve 2.0 System | Viveve Medical, Inc. | GEI | Class II | 2021-09-14 |
| K203455 | Disposable Medical Mask | Fujian Kang Chen Daily Necessities Co., Ltd. | FXX | Class II | 2021-09-13 |
| K211296 | Surgical face mask | Sunsmed Protective Products , Ltd. | FXX | Class II | 2021-09-11 |
| K212451 | Surgical Mask | Remade USA, LLC | FXX | Class II | 2021-09-10 |
| K212246 | Exofin Precision Pen | Chemence Medical, Inc. | MPN | Class II | 2021-09-09 |
| K211832 | Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask | Zhejiang Lanhine Medical Products, Ltd. | FXX | Class II | 2021-09-08 |
| K211579 | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) | Bolder Surgical, LLC | GEI | Class II | 2021-09-07 |
| K211762 | Altor Safety 4-Ply Surgical Mask (Model:62232) | Altor Safety, LLC | FXX | Class II | 2021-09-03 |
| K211637 | AROMA GRAND | Daeju Meditech Engineering Co., Ltd. | GEX | Class II | 2021-09-03 |
| K211536 | Welspun Health Surgical Mask | Welspun India Limited | FXX | Class II | 2021-09-01 |
| K211174 | IPL Hair Removal | Shenzhen Qiaochengli Technology Co., Ltd. | OHT | Class II | 2021-09-01 |
| K210951 | Leonardo Mini Blue | Ceramoptec GmbH | GEX | Class II | 2021-09-01 |
| K202204 | Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | JCT | Class II | 2021-09-01 |
| K211255 | Surgical Mask | Tianchang Kanghui Protective Products Co, Ltd. | FXX | Class II | 2021-08-28 |
| K210676 | XSTAT 30 Pouch | Revmedx, Inc. | PGZ | Class II | 2021-08-27 |
| K202746 | Surgical mask | Ningbo Jingeao Electronics, Inc. | FXX | Class II | 2021-08-27 |
| K202831 | The iMask Child's Face Mask | Pac-Dent, Inc. | OXZ | Class II | 2021-08-26 |
| K210131 | ComfortGuard Surgical Isolation Gown | Gri-Alleset, Inc. | FYC | Class II | 2021-08-26 |
| K210745 | Heel Incision Safety Lancet | SteriLance Medical (Suzhou), Inc. | FMK | Class II | 2021-08-26 |
| K211444 | CellFX System | Pulse Biosciences, Inc. | GEI | Class II | 2021-08-25 |
| K211362 | SCAR 3 | El.En Electronic Engineering Spa | GEX | Class II | 2021-08-25 |
| K211451 | Disposable Surgical Mask (non sterile) | Qinhuangdao Taizhi Medical Technology Co., Ltd. | FXX | Class II | 2021-08-25 |
| K202745 | Disposable medical face mask | Ningbo Jingeao Electronics, Inc. | FXX | Class II | 2021-08-23 |
| K201400 | npSIMS Negative Pressure Surgical Incision Management System (npSIMS) | Aatru Medical, LLC | QPX | Class II | 2021-08-23 |
| K203396 | DEKA SMARTPERIO | El.En Electronic Engineering Spa | NVK | Class II | 2021-08-23 |
| K202532 | Disposable Surgical Gowns | Anhui Medpurest Medical Technology Co.,Ltd | FYA | Class II | 2021-08-21 |
| K210698 | ECOMA Level 2 Disposable Surgical Mask with Ear Loops | Xianning Eco Medical Articles Co., Ltd. | FXX | Class II | 2021-08-19 |
| K211462 | Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask | Xiantao S&J Protective Products Co., Ltd. | FXX | Class II | 2021-08-19 |
| K211576 | WYZ Surgical Mask | Wyz Medical Supplies, LLC | FXX | Class II | 2021-08-19 |
| K211066 | Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 | Homtex, Inc. | FXX | Class II | 2021-08-19 |
| K210256 | CiRx (R) Surgical Mask | Ningbo Shun YE Medical Company, Ltd. | FXX | Class II | 2021-08-19 |
| K202425 | SurgiLattice scaffold | Tepha, Inc. | OOD | Class II | 2021-08-19 |
| K211454 | Surgical mask | Jiangsu Xingtong Biotechnology Group Co., Ltd. | FXX | Class II | 2021-08-18 |
| K211631 | Surgical Face Mask | Macheng Thimble Technology Investment Co., Ltd. | FXX | Class II | 2021-08-18 |
| K212097 | Disposable medical surgical mask | Hebei Titans Hongsen Medical Technology Co., Ltd. | FXX | Class II | 2021-08-18 |
| K210569 | Disposable Monopolar Laparoscopic Shafts and Reusable Handles | Dannik, LLC | GEI | Class II | 2021-08-16 |
| K203693 | Nisus Touch Negative Pressure Wound Therapy Pump | Cork Medical Products, LLC | OMP | Class II | 2021-08-13 |
| K211563 | Pitch-Patchs | Xiros, Ltd. | FTL | Class II | 2021-08-13 |
| K210510 | Disposable Surgical Gown | Shandong Zhushi Pharmaceutical Group Co., Ltd. | FYA | Class II | 2021-08-12 |
| K211552 | Surgical mask | Shandong Shengquan New Materials Co., Ltd. | FXX | Class II | 2021-08-11 |
| K203152 | Disposable Face Mask | Chaozhou Cecilia Technology Co., Ltd. | FXX | Class II | 2021-08-11 |
| K211353 | Medical Face Mask | Shenzhen Lyttop Healthcare Limited | FXX | Class II | 2021-08-11 |
| K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | QPZ | Class II | 2021-08-05 |
| K210643 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co., Ltd. | FXX | Class II | 2021-08-04 |
| K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter | Venclose, Inc. | GEI | Class II | 2021-08-03 |
| K211897 | Surgical Face Mask | Zhejiang Hongyu Medicali Commodity Co., Ltd. | FXX | Class II | 2021-08-03 |
| K211026 | Minitube Dentasleeve Protective Barrier Sleeves | Minitube AB | PEM | Class II | 2021-08-03 |
| K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | Careplus (M) Sdn Bhd | KGO | Class I | 2021-08-03 |
| K203538 | SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) | Medline Industries, Inc. | KGO | Class I | 2021-08-02 |
| K203174 | Disposable Medical Mask | Dong Guan Kinyet Metal Products Co., Ltd. | FXX | Class II | 2021-08-02 |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | Avery Dennison Belgie Bvba | KKX | Class II | 2021-07-30 |
| K210870 | MEO Med Disposable Medical Face Mask | Fujian Meo Medical Technology Limited | FXX | Class II | 2021-07-30 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.