Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 42
- Latest Decision
- 2024-11-15
Clearances · page 8 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K242960 | AdVance XP Male Sling System (720163-03) | Boston Scientific Corporation | OTM | Class II | 2024-11-15 |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | 2024-11-15 |
| K241930 | Veincare | Wontech Co., Ltd. | GEX | Class II | 2024-11-14 |
| K242598 | DEFINE System (AG612444A) | InMode , Ltd. | PBX | Class II | 2024-11-14 |
| K242440 | Intense Pulsed Light Treatment System (LK-PT) | Nanjing Bestview Laser S&T Co., Ltd. | ONF | Class II | 2024-11-14 |
| K242502 | Aurelia Surgical Mask ASTM Level-3 (2130) | Supermax Healthcare Canada Supermax Medical | FXX | Class II | 2024-11-12 |
| K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | GEI | Class II | 2024-11-08 |
| K242286 | Superflow Prime Treatment System (ASP-1M) | Guangzhou Aimira Innovation Technology Co, Ltd. | GEI | Class II | 2024-11-08 |
| K242382 | décoLITE LED Device | iSMART Developments, Ltd. | OHS | Class II | 2024-11-08 |
| K240429 | Trilogy Tissue Marker | Inrad, Inc. | NEU | Class II | 2024-11-07 |
| K242595 | Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) | Shenzhen Greatro Electronic Technology Co., Ltd. | OHT | Class II | 2024-11-07 |
| K242803 | Compound W Skin Tag Remover | Medtech Products, Inc. | GEH | Class II | 2024-11-06 |
| K242039 | Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2024-11-06 |
| K242664 | gentleheel® Adult Incision Device | Gri-Alleset, Inc. | FMK | Class II | 2024-11-05 |
| K231287 | POTENZA | Jeisys Medical, Inc. | GEI | Class II | 2024-11-05 |
| K243217 | Legend X Desktop System | Pollogen, Ltd. | GEI | Class II | 2024-11-01 |
| K241646 | ORTIV (ORTIV-BL, ORTIV-WH) | Mvitro Co., Ltd. | GEX | Class II | 2024-11-01 |
| K242627 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | FMK | Class II | 2024-10-30 |
| K241902 | Edison System | HistoSonics, Inc. | QGM | Class II | 2024-10-30 |
| K243126 | TRACHEOBRONXANE DUMON® | Novatech SA | NWA | Class II | 2024-10-29 |
| K242622 | Sterile Lancets for Single Use | Ningbo Caremed Medical Products Co., Ltd. | QRK | Class II | 2024-10-28 |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC | GDW | Class II | 2024-10-28 |
| K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | OHS | Class II | 2024-10-28 |
| DEN230084 | Dexter L6 System | Distalmotion SA | SDD | Class II | 2024-10-25 |
| K243030 | Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) | Ulike Co., Ltd. | OHT | Class II | 2024-10-25 |
| K242625 | Freeze Point & Private Label Versions | Cryoconcepts LP | GEH | Class II | 2024-10-25 |
| K240543 | Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) | Medency S.R.L. | GEX | Class II | 2024-10-24 |
| K242086 | MagDI System (MAG-01, DS-01) | Gt Metabolic Solutions, Inc. | SAH | Class II | 2024-10-24 |
| K242183 | Fractional CO2 Laser Therapy System (EXFU CO2) | Weifang Mingliang Electronics Co., Ltd. | GEX | Class II | 2024-10-23 |
| K242250 | PuraStat | 3-D Matrix Europe SAS | QAU | Class II | 2024-10-22 |
| K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | GEI | Class II | 2024-10-21 |
| K242157 | Anovo Surgical System (Model 6Ne) | Momentis Surgical , Ltd. | QNM | Class II | 2024-10-21 |
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | Boston Scientific Corp | GEH | Class II | 2024-10-18 |
| K242132 | FREDDO | Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda | GEX | Class II | 2024-10-18 |
| K242435 | Dental Barrier and Sleeves | Wellmed Dental Medical Supply Co., Ltd. | PEM | Class II | 2024-10-18 |
| K240916 | Surgical Face Mask (Tie on/ Ear loops) | Xiantao Daoqi Plastic Co., Ltd. | FXX | Class II | 2024-10-18 |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | Coloplast Corp. | PAH | Class II | 2024-10-18 |
| K240226 | Pixie Skin Tag | Oystershell NV | ORE | 2024-10-18 | |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture | Safepath Medical, Inc. | GAP | Class II | 2024-10-18 |
| K242197 | IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) | Shenzhen Huaruibo Electric Appliances Co., Ltd. | OHT | Class II | 2024-10-17 |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Instruments | FYA | Class II | 2024-10-16 |
| K242035 | Accure Laser System | Accure Acne, Inc. | GEX | Class II | 2024-10-11 |
| DEN230078 | Versius Surgical System | Cmr Surgical Limited | SCV | Class II | 2024-10-11 |
| K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | OHS | Class II | 2024-10-11 |
| K233265 | Monotime and Optime R | Peters Surgical | GAM | Class II | 2024-10-11 |
| K241951 | Lasya-Trinity | BLUECORE COMPANY Co., Ltd. | GEX | Class II | 2024-10-10 |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | Quanta System Spa | GEX | Class II | 2024-10-10 |
| K240991 | eMVFit (MVF-10M) | Weero Co., Ltd. | PBX | Class II | 2024-10-09 |
| K241355 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | QAI | Class II | 2024-10-09 |
| K231948 | MEDIYAG | Medicreations, LLC | GEX | Class II | 2024-10-09 |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) | Fengh Medical Co., Ltd. | GDW | Class II | 2024-10-04 |
| K240376 | Electroporation System (N3000) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | OAB | Class II | 2024-10-04 |
| K241907 | Anovo Surgical System (model 6N) | Momentis Surgical , Ltd. | QNM | Class II | 2024-10-02 |
| K242302 | RejuvaKnee Collagen Meniscus Implant | Collagen Matrix, Inc. | OLC | Class II | 2024-10-02 |
| K241952 | AQUABEAM Robotic System (AB2000) | Procept Biorobotics | PZP | Class II | 2024-09-30 |
| K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 | Hyundae Meditech Co., Ltd. | NEW | Class II | 2024-09-27 |
| K241933 | HIGHERDOSE Red and Infrared Light Mask (MK66-L) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2024-09-27 |
| K242206 | ACTIVO | Daeju Meditech Engineering Co., Ltd. | GEX | Class II | 2024-09-27 |
| K234149 | MOLLI 2 System | Molli Surgical, Inc. | NEU | Class II | 2024-09-26 |
| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical, Inc. | NEY | Class II | 2024-09-26 |
| K242204 | Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) | Dongguan Quanding Medical Supplies Co., Ltd. | GEI | Class II | 2024-09-25 |
| K241535 | Vybe RF II | ShenB Co., Ltd. | GEI | Class II | 2024-09-25 |
| K240042 | MOLLI 2 System | Molli Surgical, Inc. | NEU | Class II | 2024-09-25 |
| K241860 | Diode Laser Hair Removal System | Beijing Winkonlaser Technology Limited | GEX | Class II | 2024-09-25 |
| K240776 | Celsio Flexible Cryocatheter System | Endocision Technologies, Inc. | GEH | Class II | 2024-09-24 |
| K241834 | IPL Hair Removal Device (BE932C, BE932D, BE932E) | Shenzhen Yang WO Electronic Co., Ltd. | OHT | Class II | 2024-09-23 |
| K240604 | MTONE EVO (MTONE EVO) | M&T S.R.L. | GEX | Class II | 2024-09-20 |
| K241825 | Microwave Ablation Antennas | Canyon Medical, Inc. | NEY | Class II | 2024-09-20 |
| K241771 | Liftendo; Liftendo 2.0 | Medical San Indústria DE Equipamentos Médicos Ltda. | GEX | Class II | 2024-09-16 |
| K241762 | OneMark | View Point Medical | NEU | Class II | 2024-09-16 |
| K240188 | Vitruvian Liposaber | Black & Black Surgical, Inc. | QPB | Class II | 2024-09-13 |
| K233732 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | OOK | Class II | 2024-09-12 |
| K241214 | ProPel SG3 Surgical Gown | Standard Textile Co., Inc. | FYA | Class II | 2024-09-10 |
| K241205 | Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2024-09-09 |
| K242349 | FoLix | Lumenis Be, Ltd. | GEX | Class II | 2024-09-09 |
| K241672 | COPRO 3 | Amt Engineering Co., Ltd. | GEX | Class II | 2024-09-06 |
| K231741 | ProGear® Surgical Mask with Oxafence®, Model AV82030 | Prestige Ameritech | OUK | Class II | 2024-09-05 |
| K241155 | Cold Sore Device (QPZ-03) | Shenzhen Nuon Medical Equipment Co., Ltd. | OKJ | Class II | 2024-09-05 |
| K242251 | Litho 60; Litho 100; Litho 150 | Quanta System Spa | GEX | Class II | 2024-09-03 |
| K241400 | SkinPen Precision Elite System | Crown Aesthetics | QAI | Class II | 2024-08-29 |
| K241881 | IPL Hair Removal Device (JM-843, JM-865, JM-638) | Shenzhen Junmei Technology Co., Ltd. | OHT | Class II | 2024-08-29 |
| K242316 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | FMK | Class II | 2024-08-28 |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | AtriCure, Inc. | OCL | Class II | 2024-08-27 |
| K242044 | FiAPC plus probes | Erbe Elektromedizin GmbH | GEI | Class II | 2024-08-26 |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | Primed Medical Products, Inc. | FXX | Class II | 2024-08-26 |
| K242202 | LightWalker Laser System Family | Fotona D.O.O. | GEX | Class II | 2024-08-23 |
| K240790 | Polyisoprene Surgical gloves | Suzhou Colour-Way New Material Co., Ltd. | KGO | Class I | 2024-08-23 |
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | GEX | Class II | 2024-08-23 |
| K242142 | Fraxel® FTX Laser System | Solta Medical | GEX | Class II | 2024-08-21 |
| K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical | OMP | Class II | 2024-08-21 |
| K240314 | MULA (K2-A1) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | ONF | Class II | 2024-08-21 |
| K234114 | CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) | Okapi Medical, LLC Dba Resivant Medical | MPN | Class II | 2024-08-20 |
| K241102 | Luna 4 plus | Foreo, Inc. | OHS | Class II | 2024-08-20 |
| K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | Procept Biorobotics | PZP | Class II | 2024-08-20 |
| K241848 | MedtFine Safety Lancet | Ningbo Caremed Medical Products Co., Ltd. | FMK | Class II | 2024-08-20 |
| K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. | OMP | Class II | 2024-08-19 |
| K241810 | MICROLET®NEXT Lancet | Ascensia Diabetes Care U.S., Inc. | QRK | Class II | 2024-08-15 |
| K241522 | NPseal (20 and 25) | Guard Medical, Inc. | OKO | Class II | 2024-08-15 |
| K241750 | Medifun Safety Lancet ( MSL1 series) | Medifun Corporation | FMK | Class II | 2024-08-15 |
| K241547 | Diode Laser Therapy Device (DF-DIODE LASER-S1) | Weifang Dragonfly Electronics Technology Co., Ltd. | GEX | Class II | 2024-08-13 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.