Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 33
- Latest Decision
- 2022-05-24
Clearances · page 18 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213481 | Medline General Surgery Tray | Medline Industries, Inc. | LRO | Class II | 2022-05-24 |
| K211878 | LiquiBand XL | Advanced Medical Solutions Limited | OMD | Class II | 2022-05-23 |
| K220867 | Tapestry Biointegrative Implant | Embody, Inc. | OWY | Class II | 2022-05-23 |
| K220532 | Disposable surgical mask | Xiamen Blue Star Enterprise Co., Ltd. | FXX | Class II | 2022-05-23 |
| K210545 | Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine | Marci Beauty, Inc. | OLP | Class II | 2022-05-20 |
| K220838 | Artisan Bone Plug, Universal Cement Restrictor | Howmedica Osteonics, Dba Stryker Orthopaedics | LZN | Class II | 2022-05-20 |
| K220381 | Diode Laser Therapy Systems | Beijing Lasertell Medical Co., Ltd. | GEX | Class II | 2022-05-20 |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. | FMK | Class II | 2022-05-19 |
| K220824 | Medical Surgical Mask (Planar type) | Hunan Chopard Medical Devices Co., Ltd. | FXX | Class II | 2022-05-19 |
| K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | 2022-05-19 |
| K221134 | Procedure Mask with Ear Loops and Surgical Mask with Ties | Safesource Direct, LLC | FXX | Class II | 2022-05-19 |
| K211534 | RevoLix HTL | Lisa Laser Products GmbH | GEX | Class II | 2022-05-19 |
| K220333 | Medline Orbis LVL 3 Surgical Gown | Medline Industries, LP | FYA | Class II | 2022-05-18 |
| K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler | Gri-Alleset, Inc. | FMK | Class II | 2022-05-18 |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories | Lumenis Be, Ltd. | GEX | Class II | 2022-05-18 |
| K213840 | MolecuLight I:X | MolecuLight, Inc. | QJF | Class II | 2022-05-18 |
| K220372 | Heel Stick Safety Lancet (HHZ-II, HHZ-III) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | 2022-05-17 |
| K220194 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | FXX | Class II | 2022-05-17 |
| K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO , Ltd. | OHS | Class II | 2022-05-17 |
| K213832 | AAMI3 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | FYC | Class II | 2022-05-16 |
| K220669 | IPL HAIR REMOVAL HANDSET, Model: IPL-666 | Shenzhen Junbobeauty Technology Co., Ltd. | OHT | Class II | 2022-05-16 |
| K220749 | Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP | Unimax Medical Products Co., Ltd. | FXX | Class II | 2022-05-13 |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | Stryker Sustainability Solutions | NUJ | Class II | 2022-05-13 |
| K220186 | Zone Specific AIM | Conmed Corporation | GAT | Class II | 2022-05-13 |
| K221001 | IPL Home Use Hair Removal Device | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | OHT | Class II | 2022-05-12 |
| K213001 | Procedure Mask, Surgical Mask | A Plus International, Inc. | FXX | Class II | 2022-05-11 |
| K220662 | Disposable Barrier Sleeves | Premium Plus (Dongguan) Limited | PEM | Class II | 2022-05-11 |
| K213177 | Plus Medical Cover Gown | Foshan Nanhai Plus Medical Co, Ltd. | FYA | Class II | 2022-05-11 |
| K214008 | Dental diode laser | Shenzhen Soga Technology Co., Ltd. | NVK | Class II | 2022-05-10 |
| K214108 | Medline Orbis Chemo Surgical Gown | Medline Industries, LP | FYA | Class II | 2022-05-06 |
| K221013 | GIA Auto Suture Stapler with DST Series Technology | Covidien | GDW | Class II | 2022-05-05 |
| K220041 | HandPICO | Vydence Medical Industria E Comercio Ltda | GEX | Class II | 2022-05-05 |
| K211036 | Plus Medical Chemotherapy Gown | Foshan Nanhai Plus Medical Co, Ltd. | FYA | Class II | 2022-05-04 |
| K213594 | ECHOLASER X4 | Elesta S.P.A | GEX | Class II | 2022-05-03 |
| K212422 | Disposable Surgical Isolation Gown | Crown Name Disposable Hygiene Products Fty., Ltd. | FYC | Class II | 2022-04-29 |
| K221005 | EEA Circular Stapler with Tri-Staple Technology | Covidien | GDW | Class II | 2022-04-29 |
| K220608 | Accu-Chek FastClix Blood Lancing System | Roche Diabetes Care, Inc. | QRL | Class II | 2022-04-29 |
| K221006 | GIA Stapler with Tri-Staple Technology | Covidien | GDW | Class II | 2022-04-29 |
| K220189 | LISA Laser Surgical Fibers | Omni-Guide Holdings, Inc. | GEX | Class II | 2022-04-29 |
| K220592 | Venus BlissMAX | Venus Concept USA, Inc. | PBX | Class II | 2022-04-27 |
| K220645 | Hand-held IPL device (JOVS Hair Removal Device) | Shenzhen Qianyu Technology Co., Ltd. | OHT | Class II | 2022-04-27 |
| K220222 | IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 | Shenzhen Yuwei Electronic Technology Co., Ltd. | OHT | Class II | 2022-04-26 |
| K220219 | PERMALOOP Suture, PERMATAPE Suture | Medos International SARL | GAT | Class II | 2022-04-26 |
| K220487 | Disposable Medical Face Mask | Hubei Mediunion Medical Products Co., Ltd. | FXX | Class II | 2022-04-26 |
| K220512 | Disposable Surgical Face Mask (M01, M02) | Fomed Industries, Inc. | FXX | Class II | 2022-04-25 |
| K213889 | PicoStar | Asclepion Laser Technologies GmbH | GEX | Class II | 2022-04-22 |
| K203855 | CoNextions TR Tendon Repair System | Conextions Medical | GAQ | Class II | 2022-04-22 |
| K220840 | 1 Series Phototherapy Equipment | Daavlin Distributing Co. | FTC | Class II | 2022-04-22 |
| K210183 | Waterlase iPLus | Biolase, Inc. | GEX | Class II | 2022-04-21 |
| K212158 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | NEU | Class II | 2022-04-21 |
| K213484 | SmoothCool HR System | Jeisys Medical, Inc. | GEX | Class II | 2022-04-20 |
| K213350 | mJOULE System and Accessories | Sciton, Inc | GEX | Class II | 2022-04-15 |
| K210148 | Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460) | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. | FYC | Class II | 2022-04-13 |
| K210634 | MCL 31 Dermablate System | Asclepion Laser Technologies GmbH | GEX | Class II | 2022-04-13 |
| K213557 | Finexel | SNJ Co., Ltd. | GEX | Class II | 2022-04-12 |
| K214088 | Disposable Surgical Gown | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | FYA | Class II | 2022-04-12 |
| K220103 | LED Therapy Device (Planar LED/Planar LED mini) | Shenzhen Leaflife Technology Co., Ltd. | GEX | Class II | 2022-04-12 |
| K212881 | Intense Pulsed Light (IPL) System | Shenzhen Fansizhe Science and Technology Co., Ltd. | OHT | Class II | 2022-04-11 |
| K212882 | SCOUT BX Delivery System | Merit Medical Systems, Inc. | NEU | Class II | 2022-04-08 |
| K210860 | Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 | Gri-Alleset, Inc. | FXX | Class II | 2022-04-07 |
| K211203 | Green OR Reprocessed Aquamantys Bipolar Sealer | Green Or, LLC | NUJ | Class II | 2022-04-07 |
| K212203 | Dong Hai Xiang Surgical Mask | Taizhou Donghaixiang Protective Equipment Co., Ltd. | FXX | Class II | 2022-04-07 |
| K202106 | Plasmage System | Brera Medical, Inc. | GEI | Class II | 2022-04-06 |
| K214085 | Disposable Medical Mask | Hubei Wanli Protective Products Co., Ltd. | FXX | Class II | 2022-04-06 |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | FMK | Class II | 2022-04-05 |
| K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | FXX | Class II | 2022-04-05 |
| K212947 | Trinity Plus Wrinkle Reducer | Carol Cole Company Dba Nuface | OHS | Class II | 2022-04-02 |
| K213736 | Medical Face Mask | Hangzhou Runheng Medical Co., Ltd. | FXX | Class II | 2022-03-31 |
| K212888 | Golnit Nylon Monofilament Suture | Antarma, LLC Dba Golnit Sutures | GAR | Class II | 2022-03-31 |
| K220674 | TargetCool | Recensmedical, Inc. | GEH | Class II | 2022-03-31 |
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | Dukal Corporation | QPC | Class II | 2022-03-30 |
| K210422 | INTAI Surgical Mask (non-sterile) | Intai Technology Corp. | FXX | Class II | 2022-03-30 |
| K211681 | EON | Dominion Aesthetic Technologies, Inc. | PKT | Class II | 2022-03-30 |
| K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Dukal Corporation | OXZ | Class II | 2022-03-29 |
| K214113 | Hand-held IPL device(JOVS Graphene Hair Removal Device) | Shenzhen Qianyu Technology Co., Ltd. | OHT | Class II | 2022-03-28 |
| K220637 | 3 Ply Medical Grade Single Use Procedural Disposable Face Mask | Kdi Med Supply | FXX | Class II | 2022-03-25 |
| K220187 | Medical Surgical Mask (Model: JM92, JM92B) | Guangdong Jia Mei Biological Technology Co.Ltd | FXX | Class II | 2022-03-25 |
| K220519 | Erchonia Zerona Z-Bed | Erchonia Corporation | OLI | Class II | 2022-03-24 |
| K202903 | Surgical Face Mask | Rizhao Sanqi Medical & Health Articles Co., Ltd. | FXX | Class II | 2022-03-24 |
| K213461 | AviClear Laser System | Cutera, Inc. | GEX | Class II | 2022-03-24 |
| K214101 | Project E Beauty LED Light Therapy Mask (Model: PE730) | Duplex International Trading Limited | OHS | Class II | 2022-03-23 |
| K212726 | Disposable Medical Surgical Mask | Hubei Huaqiang High-Tech Co., Ltd. | FXX | Class II | 2022-03-23 |
| K210693 | PLEXR PLUS | Gmv S.R.L. | GEI | Class II | 2022-03-22 |
| K214103 | Shani Darden LED light therapy mask | Harpar Grace International | OLP | Class II | 2022-03-22 |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown | Dukal Corporation | FYA | Class II | 2022-03-18 |
| K212891 | TempSure System | Cynosure, LLC | GEI | Class II | 2022-03-18 |
| K210823 | LYMA Laser | Lyma Life , Ltd. | OHS | Class II | 2022-03-18 |
| K211132 | ARISTE AB Mesh | Ariste Medical, LLC | FTL | Class II | 2022-03-18 |
| K210315 | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps | Modern Medical Equipment Manufacturing, Ltd. | GEI | Class II | 2022-03-17 |
| K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit | Millennium Medical Technologies Inc (Dba Cellmyx) | MUU | Class II | 2022-03-16 |
| K220426 | Fiber Dust PRO | Quanta System Spa | GEX | Class II | 2022-03-16 |
| K213894 | DWFritz ASM2000 | Dwfritz Automation, Inc. | FXX | Class II | 2022-03-14 |
| K212330 | Yadu Medical Face Mask (Level 1) | Henan Yadu Industrial Co., Ltd. | FXX | Class II | 2022-03-14 |
| K213806 | Disposable Medical Face Mask | Xiantao Zhibo Nonwoven Products Co., Ltd. | FXX | Class II | 2022-03-12 |
| K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart | Conmed Corporation | GEI | Class II | 2022-03-11 |
| K213658 | DEKA SMARTPERIO | El.En Electronic Engineering Spa | NVK | Class II | 2022-03-11 |
| K201351 | Maxima Surgical Gown | Elevate Textiles | FYA | Class II | 2022-03-11 |
| K213534 | PHantom Trilogy | Resurgeonz, LLC | OLI | Class II | 2022-03-11 |
| K213957 | Demetra Dermatoscope BDEM-01 | Barco N.V. | PSN | Class II | 2022-03-11 |
| K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | NVK | Class II | 2022-03-10 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.