Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 43
- Latest Decision
- 2025-06-04
Clearances · page 6 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K243843 | Tendon Protect (50242) | Kerecis Limited | OWY | Class II | 2025-06-04 |
| K250657 | gi2000 Electrosurgical Generator | Cintron Medical Corporation | GEI | Class II | 2025-06-03 |
| K250598 | Endoform Reconstructive Template - PLGA | Aroa Biosurgery , Ltd. | FTM | Class II | 2025-06-03 |
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) | Maquet Cardiovascular, LLC | GEI | Class II | 2025-05-30 |
| K243522 | ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH | FYA | Class II | 2025-05-30 |
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | 2025-05-30 |
| K250195 | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) | Matelaser, Inc. | GEX | Class II | 2025-05-30 |
| K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | QUW | Class II | 2025-05-30 |
| K250581 | KALA Red Light Face Mask (KALA-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2025-05-30 |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation | ONO | Class II | 2025-05-29 |
| K250048 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | GEI | Class II | 2025-05-29 |
| K243480 | SuturePatch Tissue Reinforcement | Arthrex, Inc. | OWX | Class II | 2025-05-29 |
| K250606 | Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. | PEM | Class II | 2025-05-29 |
| K243716 | Zionic Pro Max (Radiofrequency) | Termosalud S.L. | PBX | Class II | 2025-05-28 |
| K250435 | Dexter L6 System | Distalmotion SA | SDD | Class II | 2025-05-27 |
| K250938 | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2025-05-23 |
| K250384 | IPL400 | El Global Trade, Ltd. | OHT | Class II | 2025-05-23 |
| K250532 | Solawave 2-in-1 Skincare Mini (Model: 61043) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2025-05-22 |
| K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | Cryoconcepts LP | GEH | Class II | 2025-05-22 |
| K251230 | The Alma Hybrid Laser System | Alma Lasers, Inc. | GEX | Class II | 2025-05-21 |
| K243302 | 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. | OXF | Class II | 2025-05-21 |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | Shenzhen Desida Technology Co., Ltd. | BTA | Class II | 2025-05-16 |
| K243176 | BLESSING System | Cellah Medical Co., Ltd. | GEI | Class II | 2025-05-16 |
| K251156 | NPseal | Guard Medical, Inc. | OKO | Class II | 2025-05-15 |
| K240857 | Youmagic FLM System (YM5-U1) | We Medical Technology (Wuxi) Co., Ltd. | GEI | Class II | 2025-05-15 |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC | GDW | Class II | 2025-05-14 |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2025-05-14 |
| K250813 | MICROLET®NEXT 2 Lancing Device | Ascensia Diabetes Care U.S., Inc. | QRL | Class II | 2025-05-14 |
| K251288 | Veincare | Wontech Co., Ltd. | GEX | Class II | 2025-05-14 |
| K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | Ulthera, Inc. | OHV | Class II | 2025-05-13 |
| K250431 | Medical Diode Laser Hair Removal System (MNLT-D1) | Shandong Moonlight Electronics Tech Co., Ltd. | GEX | Class II | 2025-05-12 |
| K244050 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | QPB | Class II | 2025-05-12 |
| K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. | GEI | Class II | 2025-05-09 |
| K243764 | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) | Wuhan Pioon Technology Co., Ltd. | NVK | Class II | 2025-05-08 |
| K251111 | Cary | Excitus AS | JCX | Class II | 2025-05-07 |
| K251094 | Alma Veil | Wontech Co., Ltd. | GEX | Class II | 2025-05-06 |
| K243017 | IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) | Foshan Newface Electronic Technology Co., Ltd. | OHT | Class II | 2025-05-06 |
| K250253 | IPL Hair Removal Device (KCA511/KCA516/KCA522) | Dongguan Boyuan Intelligent Technology Co.,Ltd | OHT | Class II | 2025-05-06 |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) | FYA | Class II | 2025-05-05 |
| K251056 | Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. | QNM | Class II | 2025-05-02 |
| K244020 | Wrinkle Treatment Device (JM1, JM2B) | Shenzhen Qianyu Technology Co., Ltd. | OHS | Class II | 2025-05-01 |
| K250977 | Suture-TOOL System | Suturion AB | NEW | Class II | 2025-04-28 |
| K242951 | Diode laser hair removal machine (QDTM-02) | Beijing Nubway S&T Co., Ltd. | GEX | Class II | 2025-04-28 |
| K251101 | AIRO Suction Unit (AIRO-01) | Cro, LLC | BTA | Class II | 2025-04-26 |
| K242469 | RFMagik Lite | Agnes Medical Co., Ltd. | GEI | Class II | 2025-04-25 |
| K244026 | PAL 7020 Console | Microaire Surgical Instruments, LLC | QPB | Class II | 2025-04-25 |
| K250206 | Diode laser system (Night Universe; Predator) | Ivylaser (Beijing) Technology Co.,Ltd | GEX | Class II | 2025-04-24 |
| K250183 | CO2 Laser System (CO2 Laser SST-L23) | Zhuozhou Summer Star Technologies Co., Ltd. | GEX | Class II | 2025-04-24 |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023) | Shenzhen Kingboom Technology Co., Ltd. | BTA | Class II | 2025-04-23 |
| K250869 | Parietene Macroporous Mesh (PPM5050 ) | Sofradim Production | FTL | Class II | 2025-04-23 |
| K250224 | handLITE (TN19S) | iSMART Developments, Ltd. | ONE | Class II | 2025-04-18 |
| K250455 | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | Fluoptics Sas (A Getinge Group Company} | QDG | Class II | 2025-04-17 |
| K241733 | HEBE (NP0000763) | Novasonix Technology S.L. | PBX | Class II | 2025-04-16 |
| K250809 | Stellar M22 | Lumenis Be, Ltd. | GEX | Class II | 2025-04-16 |
| K250327 | OptaBlate Radiofrequency (RF) Generator System | Stryker Instruments | GEI | Class II | 2025-04-15 |
| K243055 | Préime DermaFacial Collagen+ | EMA Aesthetics , Ltd. | PBX | Class II | 2025-04-15 |
| K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | GEH | Class II | 2025-04-15 |
| K242773 | Electro Lube NXT | Steris | GEI | Class II | 2025-04-15 |
| K250402 | AVAVA Skin Treatment System | AVAVA, Inc. | ONG | Class II | 2025-04-14 |
| K243044 | Alma Harmony | Alma Lasers, Inc. | GEX | Class II | 2025-04-11 |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. | FTL | Class II | 2025-04-09 |
| K243722 | Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) | Selio Medical Limited | OMT | Class II | 2025-04-08 |
| K242151 | Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) | Shenzhen Nuon Medical Equipment Co., Ltd. | OHS | Class II | 2025-04-08 |
| K250708 | NPseal | Guard Medical, Inc. | OKO | Class II | 2025-04-08 |
| K243143 | E-PEN (E-PEN) | Bomtech Electronics Co., Ltd. | QAI | Class II | 2025-04-07 |
| K242385 | LED Therapy Mask (MN1, M226) | Shenzhen Borria Technology Co., Ltd. | OHS | Class II | 2025-04-07 |
| K250395 | BioBrace ® RC Delivery System | Conmed Corporation | ORQ | Class II | 2025-04-07 |
| K250425 | Ultraviolet Phototherapy Device | APK Technology Co., Ltd. | FTC | Class II | 2025-04-07 |
| K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) | Wuhan Pioon Technology Co., Ltd. | GEX | Class II | 2025-04-04 |
| K242068 | LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co.,Ltd | OLP | Class II | 2025-04-04 |
| K250018 | Medical Diode Laser Systems (THEIA808) | Gigaalaser Company , Ltd. | GEX | Class II | 2025-04-01 |
| K250189 | AdvaTx | Advalight Aps | GEX | Class II | 2025-04-01 |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | MUM | Class II | 2025-03-31 |
| K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | GAT | Class II | 2025-03-27 |
| K242669 | SnapshotGLO (KB100) | Kent Imaging, Inc. | QJF | Class II | 2025-03-26 |
| K250194 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2025-03-26 |
| K250125 | LMNT O2 | Xplr , Ltd. | OHS | Class II | 2025-03-24 |
| K243642 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | NEU | Class II | 2025-03-24 |
| K243630 | Medical Laser System Incanto / Evoline Platinum /Evoline | Solar LS Cjsc | GEX | Class II | 2025-03-21 |
| K243451 | FiAPC plus probes | Erbe Elektromedizin GmbH | GEI | Class II | 2025-03-21 |
| K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) | Gigaalaser Company , Ltd. | GEX | Class II | 2025-03-19 |
| K242241 | Sunny | ShenB Co., Ltd. | GEI | Class II | 2025-03-19 |
| K243472 | 1NEED Pro | Campomats S.R.L. | QAI | Class II | 2025-03-19 |
| K250131 | IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) | Mustech Electronics Co., Limited | OHT | Class II | 2025-03-19 |
| K250171 | IPL Hair Removal Device (BE965A, BE965B, BE965C) | Shenzhen Yang WO Electronic Co., Ltd. | OHT | Class II | 2025-03-19 |
| K250413 | Aglaia LED Beauty Device (BP-D2309) | Shenzhen Perfect Idea Technology Limited | OHS | Class II | 2025-03-18 |
| K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | POD | Class II | 2025-03-18 |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) | Boston Aesthetics, Inc. | FTC | Class II | 2025-03-13 |
| K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | GEH | Class II | 2025-03-13 |
| K250113 | neoLaser Laser Surgery Fibers | G.N.S Neolaser , Ltd. | GEX | Class II | 2025-03-13 |
| K243993 | Photon Therapy Apparatus (BL-10) | Xemis Medical Technology (Shenzhen) Co., Ltd. | GEX | Class II | 2025-03-13 |
| K243957 | PICOALEX | Wontech Co., Ltd. | GEX | Class II | 2025-03-12 |
| K250188 | Wound Treatment System (VHT-200) | Vaporox, Inc. | KPJ | Class II | 2025-03-10 |
| K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C | Atmos Medizintechnik GmbH & Co. KG | BTA | Class II | 2025-03-07 |
| K242207 | NOABLE LASER | Daeju Meditech Engineering Co., Ltd. | GEX | Class II | 2025-03-07 |
| K241790 | XCELLARISPRO TWIST microneedling device | Dermaroller GmbH | QAI | Class II | 2025-03-06 |
| K242943 | Q Switched Nd:YAG Laser machine (QNHF-01) | Beijing Nubway S&T Co., Ltd. | GEX | Class II | 2025-03-03 |
| K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2025-03-03 |
| K243359 | MagDI System (MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | SAH | Class II | 2025-02-28 |
| K250021 | Rotium | Nanofiber Solutions, LLC | OWW | Class II | 2025-02-27 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.