Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 39
- Latest Decision
- 2024-08-13
Clearances · page 9 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K241699 | SUPER VELOCE | Ilooda Co,., Ltd. | GEX | Class II | 2024-08-13 |
| K241656 | Eneka Selectif | Termosalud | GEX | Class II | 2024-08-12 |
| K240868 | Ultravision2 IonPencil | Alesi Surgical Limited | PQM | Class II | 2024-08-12 |
| K241376 | HyperSuture All Blue Extension Line | Threadstone, LLC | GAT | Class II | 2024-08-09 |
| K231950 | MEDIDIODE | Medicreations, LLC | GEX | Class II | 2024-08-09 |
| K212969 | Liposaver | Lhbiomed Co., Ltd. | QPB | Class II | 2024-08-07 |
| K240782 | CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) | Pulse Biosciences, Inc. | GEI | Class II | 2024-08-05 |
| K240932 | HybridTherm System | Erbe Elektromedizin GmbH | GEI | Class II | 2024-08-05 |
| K241635 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | GEI | Class II | 2024-08-05 |
| K240127 | PlumeSafe X5 Smoke Management System | Conmed Corporation | FYD | Class II | 2024-08-05 |
| K233571 | GCI Surgical Gown | George Courey, Inc. | FYA | Class II | 2024-08-02 |
| K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | Intuitive Surgical | GEI | Class II | 2024-08-02 |
| K241642 | Diode Laser Hair Removal System (MBT-Diode Laser) | Beijing Mega Beauty Technology Co., Ltd. | GEX | Class II | 2024-08-02 |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. | PZX | Class II | 2024-07-29 |
| K233723 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | FXX | Class II | 2024-07-29 |
| K241906 | BioBrace® Reinforced Implant | Conmed Corporation | OWW | Class II | 2024-07-29 |
| K234131 | Resolv Endoscopic Hemostat System | Hemostasis, LLC | QAU | Class II | 2024-07-26 |
| K241515 | NEXA NPWT System | Nexa Medical Limited | OMP | Class II | 2024-07-26 |
| K241203 | PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT) | Dongguan Hunter Electronic Technology Co., Ltd. | OHS | Class II | 2024-07-25 |
| K240780 | InMode RF System | InMode , Ltd. | GEI | Class II | 2024-07-24 |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | Pentax of America, Inc. | GEH | Class II | 2024-07-24 |
| K241116 | Onycho Laser V | Terasysd&C, Inc. | PDZ | Class II | 2024-07-22 |
| K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) | Varian Medical Systems, Inc. | NEY | Class II | 2024-07-19 |
| K221495 | SOLID CLIP Single Use Clip Applier | Medscope Biotech Co., Ltd. | FZP | Class II | 2024-07-18 |
| K240616 | FAQ (102) | Foreo, Inc. | PAY | Class II | 2024-07-15 |
| K233458 | CM005 Standard (CM005); CM004 Mini (CM004) | Connexicon Medical , Ltd. | MPN | Class II | 2024-07-15 |
| K233460 | CM00622 LINC Skin Closure System (CM00622 LINC) | Connexicon Medical , Ltd. | OMD | Class II | 2024-07-15 |
| K240178 | RFG-01 | Zimmer Medizinsysteme GmbH | PBX | Class II | 2024-07-15 |
| K241085 | Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | Covidien, LLC | GEI | Class II | 2024-07-12 |
| K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) | Megadyne Medical Products, Inc. | GEI | Class II | 2024-07-12 |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | GAM | Class II | 2024-07-12 |
| K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | GEI | Class II | 2024-07-11 |
| K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Devicor Medical Products, Inc. | NEU | Class II | 2024-07-10 |
| K240016 | IPL Hair Removal Device (YT01,YT02,YT03,YT04) | Shenzhen Jianrong Biomedical Electronics Co., Ltd. | OHT | Class II | 2024-07-10 |
| K233937 | OW100S | Softwave/Trt, LLC | PZL | Class II | 2024-07-09 |
| K241343 | IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140) | Shenzhen Lescolton Electrical Appliance Co., Ltd. | OHT | Class II | 2024-07-09 |
| K241293 | LED Light Therapy Device, ELIXIR MD | Yassen Wellness, LLC | GEX | Class II | 2024-07-08 |
| K241600 | Dermablate | Asclepion Laser Technologies GmbH | GEX | Class II | 2024-07-03 |
| DEN240013 | MagDI System | Gt Metabolic Solutions, Inc. | SAH | Class II | 2024-07-02 |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | 2024-07-02 |
| K240070 | Profound Matrix | Candela Corporation | GEI | Class II | 2024-07-01 |
| K241202 | Electric nasal aspirator (HTD2601US) | Hetaida Technology Co., Ltd. | BTA | Class II | 2024-07-01 |
| DEN240007 | BioHealx Anal Fistula Device | Signum Surgical Limited | QML | Class II | 2024-07-01 |
| K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | 2024-07-01 |
| K240572 | Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6) | Covidien, LLC | GEI | Class II | 2024-07-01 |
| K232865 | Magseed Pro Magnetic Marker System | Endomagnetics Ltd., | NEU | Class II | 2024-06-28 |
| K241406 | Lavieen | Wontech Co., Ltd. | GEX | Class II | 2024-06-28 |
| K240892 | XSense Cryoablation System with Cryoprobes | IceCure Medical , Ltd. | GEH | Class II | 2024-06-28 |
| K233123 | SILKRO | Hironic Co., Ltd. | GEI | Class II | 2024-06-24 |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY) | Wontech Co., Ltd. | GEX | Class II | 2024-06-24 |
| K241120 | Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) | Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. | OHT | Class II | 2024-06-24 |
| K240649 | Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2024-06-21 |
| K241459 | MOTUS PRO Family | El.En S.P.A. | GEX | Class II | 2024-06-21 |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | 2024-06-21 |
| K241627 | Safety Lancet (XXXV) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | 2024-06-20 |
| K240611 | IVYLASER Diode laser hair removal system (IVY-HR-Alloy) | Ivylaser (Beijing) Technology Co.,Ltd | GEX | Class II | 2024-06-20 |
| K240583 | IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W) | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | OHT | Class II | 2024-06-18 |
| K240747 | Medical Diode Laser (M2-GK) | Wuhan Pioon Technology Co., Ltd. | GEX | Class II | 2024-06-17 |
| K233991 | CanGaroo RM Antibacterial Envelope | Elutia, Inc. | FTM | Class II | 2024-06-14 |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Bios S.R.L. | GEX | Class II | 2024-06-14 |
| K241250 | 3DMax Light Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | FTL | Class II | 2024-06-14 |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | 2024-06-14 |
| K240817 | VersaWrap | Alafair Biosciences, Inc. | OWW | Class II | 2024-06-14 |
| K241358 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E | Sun Pharmaceutical Industries, Inc. | GEX | Class II | 2024-06-13 |
| K240017 | InMode System with the Morpheus8 90 Applicator | InMode , Ltd. | GEI | Class II | 2024-06-13 |
| K233007 | Picosecond Nd:YAG Laser System; PICO LEGEND | Ami, Inc. | GEX | Class II | 2024-06-12 |
| K240106 | Histofreezer V | Cryoconcepts LP | GEH | Class II | 2024-06-10 |
| K240644 | Medical Diode Laser (S1Pro) | Wuhan Pioon Technology Co., Ltd. | GEX | Class II | 2024-06-10 |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | 2024-06-07 |
| K232968 | Grande Medical Masks, Model SF-600 | Golden Grande Corp. | FXX | Class II | 2024-06-06 |
| K240657 | ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L- | Livsmed, Inc. | GEI | Class II | 2024-06-06 |
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) | Aesthetic Technology, Ltd. | GEX | Class II | 2024-06-04 |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | 2024-06-04 |
| K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | ONO | Class II | 2024-06-04 |
| K240598 | Maestro System (REF100) | Moon Surgical | FQO | Class I | 2024-06-03 |
| K241055 | Electro Lube NXT | Steris | GEI | Class II | 2024-05-31 |
| K240969 | IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | OHT | Class II | 2024-05-31 |
| K232505 | Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter | Zhejiang Curaway Medical Technology Co., Ltd. | GEI | Class II | 2024-05-30 |
| K240687 | SofWave System | Sofwave Medical, Ltd. | OHV | Class II | 2024-05-30 |
| K240784 | Temperature Sensor Probe (ABL-18TP20) | Varian Medical Systems, Inc. | NEY | Class II | 2024-05-29 |
| K240159 | InnoVoyce VYLO | Innovoyce | GEX | Class II | 2024-05-29 |
| K233344 | Regenalase Laser System | Ipg Medical | GEX | Class II | 2024-05-28 |
| K240874 | Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) | Theralaser Medtech (China) Co., Ltd. | GEX | Class II | 2024-05-28 |
| K231939 | Renasys Edge | Smith & Nephew Medical, Ltd. | OMP | Class II | 2024-05-24 |
| K241134 | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) | Kci USA, Inc. | OMP | Class II | 2024-05-23 |
| K233120 | CWM-930S, FIXER DV9 | Chungwoo Co., Ltd. | GEI | Class II | 2024-05-23 |
| K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | OXF | Class II | 2024-05-23 |
| K233884 | INUMI Flex Needle | Galvanize Therapeutics, Inc. | OAB | Class II | 2024-05-22 |
| K241126 | OviTex PRS | TELA Bio, Inc. | FTM | Class II | 2024-05-22 |
| K233099 | Gladiator | Rohrer Aesthetics, LLC | GEI | Class II | 2024-05-22 |
| K241106 | Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) | Shenzhen Mlay Intelligent Technology Co., , Ltd. | OHT | Class II | 2024-05-22 |
| K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | 2024-05-21 |
| K240520 | Diode Laser Hair Removal System (SH-VD910) | Beijing Sea Heart International Science and Technologyco.Ltd | GEX | Class II | 2024-05-20 |
| K240474 | Multi-function Platform Systems (BL-M10) | Shanghai Bele Medical Technology Co.,Ltd | GEX | Class II | 2024-05-20 |
| K220891 | Kahook Dual Blade Glide (KDB Glide) | New World Medical, Inc. | QUQ | Class II | 2024-05-17 |
| K240482 | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. | ONF | Class II | 2024-05-17 |
| K240386 | Picosecond Nd:YAG Laser Systems (BL-C10) | Shanghai Bele Medical Technology Co.,Ltd | GEX | Class II | 2024-05-16 |
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) | Owens & Minor (O&M) Halyard, Inc. | FYC | Class II | 2024-05-16 |
| K233473 | DEKA LOTUS | El.En S.P.A. | ONF | Class II | 2024-05-16 |
| K240752 | DEKA TORO | El.En S.P.A. | GEX | Class II | 2024-05-16 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.