Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 30
- Latest Decision
- 2022-10-22
Clearances · page 16 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | Wrp Asia Pacific Sdn. Bhd. | KGO | Class I | 2022-10-22 |
| K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown | Medtecs (Taiwan) Corp. | FYC | Class II | 2022-10-21 |
| K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | QAI | Class II | 2022-10-21 |
| K221643 | Hair Removal Device (Model: IPL-D26, IPL-D19) | Shenzhen Desida Technology Co., Ltd. | OHT | Class II | 2022-10-21 |
| K222547 | Electric nasal aspirator | Shenzhen Xinlianfeng Technology Co.,Ltd | BTA | Class II | 2022-10-20 |
| K221977 | Disposable Surgical Gown (G4003) | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | FYA | Class II | 2022-10-20 |
| K222856 | SOMAVAC 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | BTA | Class II | 2022-10-19 |
| K222643 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | PBY | Class II | 2022-10-19 |
| K221072 | TRUEdraw Lancing Device, Mini Lancing Device | Trividia Health | QRL | Class II | 2022-10-18 |
| K222793 | WavelinQ Generator | C.R. Bard, Inc. | GEI | Class II | 2022-10-17 |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | Arkray, Inc. | QRL | Class II | 2022-10-17 |
| K221574 | LUDWIG Electrosurgical Device | Aesthetics Biomedical | GEI | Class II | 2022-10-16 |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | Applied Medical Resources Corporation | GEI | Class II | 2022-10-14 |
| K220318 | PAL Infiltration System | Microaire Surgical Instruments, LLC | QPB | Class II | 2022-10-14 |
| K222537 | IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi | Shenzhen Ishine Technology Company Limited | OHT | Class II | 2022-10-14 |
| K221770 | Fiber Laser Treatment System | Shanghai Apolo Medical Technology Co., Ltd. | ONG | Class II | 2022-10-13 |
| K220853 | PicoWay Laser System | Candela Corporation | GEX | Class II | 2022-10-13 |
| K221989 | The Oligio | Wontech Co., Ltd. | GEI | Class II | 2022-10-13 |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | Fotona D.O.O. | GEX | Class II | 2022-10-12 |
| K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | GEX | Class II | 2022-10-12 |
| K214116 | AAMI4 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | FYC | Class II | 2022-10-11 |
| K222432 | IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 | Hunan Guangye Biotechnology Co., Ltd. | OHT | Class II | 2022-10-11 |
| K222335 | Surgical Mask | Luoyang Sunmed Devices Co., Ltd. | FXX | Class II | 2022-10-11 |
| K221830 | Apyx One Console | Apyx Medical Corporation | GEI | Class II | 2022-10-11 |
| K220092 | YADU Surgical Gowns | Henan Yadu Industrial Co., Ltd. | FYA | Class II | 2022-10-07 |
| K222369 | PURE Laser | Endymed Medical, Ltd. | GEX | Class II | 2022-10-07 |
| K222205 | Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. | OKJ | Class II | 2022-10-07 |
| K213969 | VisionAir Patient-Specific Airway Stent | New Cos Inc. Dba Visionair Solutions | NWA | Class II | 2022-10-07 |
| K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps | Katalyst Surgical, LLC | GEI | Class II | 2022-10-07 |
| K220138 | Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP | Led Spa | GEI | Class II | 2022-10-05 |
| K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | Owen Mumford, Ltd. | QRL | Class II | 2022-10-03 |
| K222376 | Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) | Shandong Lianfa Medical Plastic Products Co. , Ltd. | FMK | Class II | 2022-10-03 |
| K221778 | Disposable Safety Lancets | Suzhou Kyuan Medical Apparatus Co., Ltd. | FMK | Class II | 2022-10-03 |
| K202953 | Aurolase Therapy, Laser Delivery Device (LDD) | Nanospectra Biosciences, Inc. | GEX | Class II | 2022-10-03 |
| K222090 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | FMK | Class II | 2022-09-30 |
| K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA | Covidien | GDW | Class II | 2022-09-30 |
| K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile) | Allmed Medical (Hubei) Protective Products Co., Ltd. | FYA | Class II | 2022-09-29 |
| K222316 | IPL Hair Removal Device | Shenzhen Goodwind Technology Development Co., Ltd. | OHT | Class II | 2022-09-28 |
| K212561 | MTX-C1 | Ilooda Co,., Ltd. | GEI | Class II | 2022-09-27 |
| K214015 | Palm NRG cellulite body device (model: Palm NRG body device) | Heat IN A Click, LLC | PBX | Class II | 2022-09-26 |
| K222266 | Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | FXX | Class II | 2022-09-26 |
| K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | Bionime Corporation | QRL | Class II | 2022-09-26 |
| K222629 | Resonic Rapid Acoustic Pulse Device | Zeltiq Aesthetics, Inc. | GEX | Class II | 2022-09-25 |
| K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) | Hartalega NGC Sdn. Bhd. | KGO | Class I | 2022-09-24 |
| K222265 | Diosculpt | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | PKT | Class II | 2022-09-23 |
| K222555 | reepot Nd; YAG laser system | Ilooda Co,., Ltd. | GEX | Class II | 2022-09-23 |
| K222204 | Medical Surgical Mask | Guangzhou Zhengkang Medical Equipment Co.,Ltd | FXX | Class II | 2022-09-23 |
| K220540 | ProGrip Self-Gripping Polypropylene Mesh | Covidien | FTL | Class II | 2022-09-22 |
| K211605 | Dual Switch | Laser Engineering, Inc. | GEX | Class II | 2022-09-22 |
| K222224 | SurgiLance® Safety Lancet | Medipurpose Pte. , Ltd. | FMK | Class II | 2022-09-22 |
| K214125 | TRANBERG Thermoguide Therapy System | Clinical Laserthermia Systems, AB | ONO | Class II | 2022-09-22 |
| K213674 | CellFX System | Pulse Biosciences, Inc. | GEI | Class II | 2022-09-22 |
| K221383 | MedtFine Blood Lancet | Shanghai Carelife International Trading Co. , Ltd. | QRK | Class II | 2022-09-21 |
| K222293 | ArcSP Suprapubic Sling System | Urocure, LLC | OTN | Class II | 2022-09-21 |
| K221214 | Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 | Shenzhen Ionka Medical Technology Co., Ltd. | ONF | Class II | 2022-09-21 |
| K212359 | PWD Negative Pressure Wound Therapy System | Applied Tissue Technologies, LLC | OMP | Class II | 2022-09-21 |
| K221717 | Disposable Surgical Gown UM-148 | Unimax Medical Products Co., Ltd. | FYA | Class II | 2022-09-20 |
| K221976 | Surgical Face Mask (Non-sterile) | Xiantao Junhui Plastic Products Co., Ltd. | FXX | Class II | 2022-09-20 |
| K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown | Winner Medical Co., Ltd. | FYA | Class II | 2022-09-19 |
| K221839 | Lancet | Hebei Xinle Sci&Tech Co., Ltd. | FMK | Class II | 2022-09-19 |
| K221534 | Surgical Face Masks (Ear Loops And Tie-On) | San-M Package Co., Ltd. | FXX | Class II | 2022-09-16 |
| K202929 | Nexpowder | Nextbiomedical Co., Ltd. | QAU | Class II | 2022-09-16 |
| K221343 | ECHELON ENDOPATH Staple Line Reinforcement | Ethicon Endo-Surgery, LLC | OXC | Class II | 2022-09-16 |
| K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | Stryker Corporation | GEI | Class II | 2022-09-16 |
| K221676 | Exsalta | Drw Medical | BTA | Class II | 2022-09-16 |
| K212926 | AllureTM Surgical Mask | Allure Gift Wraps Private Limited | FXX | Class II | 2022-09-16 |
| K222468 | ArcTO Transobturator Sling System | Urocure, LLC | OTN | Class II | 2022-09-15 |
| K221597 | CO2 Laser System | Smedtrum Medical Technology Co., Ltd. | GEX | Class II | 2022-09-15 |
| K221553 | Diamond Air+ (UI04A, UI04B, UI04C) | Ulike Co., Ltd. | OHT | Class II | 2022-09-15 |
| K221761 | Solea | Convergent Dental, Inc. | NVK | Class II | 2022-09-14 |
| K222078 | Arthrex SoftStitch | Arthrex, Inc. | GAT | Class II | 2022-09-14 |
| K214035 | LAITEST Medical Face Mask | R&R Medical Corporation, Ltd. | FXX | Class II | 2022-09-13 |
| K221748 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | Guilin Hbm Health Protections, Inc. | KGO | Class I | 2022-09-13 |
| K220944 | PointCore Surgical Mask | Pointcore, Inc. | FXX | Class II | 2022-09-09 |
| K222429 | Ellusa Reusable Bipolar Cable | Ellusa, LLC | GEI | Class II | 2022-09-09 |
| K221354 | Arthrex SutureTape | Arthrex, Inc. | GAT | Class II | 2022-09-09 |
| K222425 | Ellusa Reusable Neutral Plates | Ellusa, LLC | GEI | Class II | 2022-09-08 |
| K213267 | Dynamis Pro Family | Fotona D.O.O. | GEX | Class II | 2022-09-08 |
| K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G | Owen Mumford, Ltd. | FMK | Class II | 2022-09-07 |
| K222034 | RightLance Blood Lancing System | Beijing Ruicheng Medical Supplies Co., Ltd. | QRL | Class II | 2022-09-07 |
| K222075 | CellFX System | Pulse Biosciences, Inc. | GEI | Class II | 2022-09-02 |
| K221957 | Savewo ClassicMASK | Savewo Limited | FXX | Class II | 2022-09-02 |
| K221277 | Mygen M-3004 RF Generator M-3004 | RF Medical Co., Ltd. | GEI | Class II | 2022-09-02 |
| K211178 | DURAMESH Mesh Suture | Msi | GAW | Class II | 2022-09-02 |
| K222426 | Perfetta Moderate Medical Face Mask | Phu Bao Group Company Limited | FXX | Class II | 2022-09-02 |
| K212222 | Soniquence Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | GEI | Class II | 2022-09-02 |
| K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System | ArthroCare Corporation | GEI | Class II | 2022-09-01 |
| K220531 | FOX 810, FOX 980 | A.R.C Laser GmbH | GEX | Class II | 2022-09-01 |
| K221038 | Disposable Medical Masks | Hantech Medical Device Co., Ltd. | FXX | Class II | 2022-09-01 |
| K221507 | Disposable Blood Lancet | SteriLance Medical (Suzhou), Inc. | QRK | Class II | 2022-08-31 |
| K221635 | IPL sapphire ice cooling hair remove device | Shenzhen Desida Technology Co., Ltd. | OHT | Class II | 2022-08-31 |
| K221970 | Lancing device | SteriLance Medical (Suzhou), Inc. | QRL | Class II | 2022-08-30 |
| K220067 | Medical Surgery Mask, Model:2626-7 | Dongguan Missadola Technology Co., Ltd. | FXX | Class II | 2022-08-30 |
| K221487 | NEOVEIL Staple Line Reinforcement | Gunze Limited | OXC | Class II | 2022-08-26 |
| K214058 | Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer | Conmed Corporation | GEI | Class II | 2022-08-26 |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | FTL | Class II | 2022-08-26 |
| K212253 | Apollo Duet (Model : APD-4000) | Weero Co. | PBX | Class II | 2022-08-25 |
| K221427 | V-Laser | Wontech Co., Ltd. | GEX | Class II | 2022-08-24 |
| K211771 | The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask | The Good Corporation | FXX | Class II | 2022-08-24 |
| K220268 | Picosecond Laser System (Model PS10-A and PS10-B) | Beijing Adss Development Co., Ltd. | GEX | Class II | 2022-08-23 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.