Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 36
- Latest Decision
- 2023-10-27
Clearances · page 12 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K233090 | DEKA AGAIN PRO family | El.En S.P.A. | GEX | Class II | 2023-10-27 |
| K231579 | MOLLI 2 | Molli Surgical, Inc. | NEU | Class II | 2023-10-26 |
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. | KKX | Class II | 2023-10-25 |
| K233147 | PiXel8-RF | Rohrer Aesthetics | GEI | Class II | 2023-10-25 |
| K222997 | VVR Generator system | Starmed Co., Ltd. | GEI | Class II | 2023-10-25 |
| K231327 | POWERSEAL Sealer and Divider | Gyrus Acmi, Inc. | GEI | Class II | 2023-10-25 |
| K233185 | MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System | C2dx, Inc. | GEI | Class II | 2023-10-24 |
| K232223 | PlaDuo System | ShenB Co., Ltd. | GEI | Class II | 2023-10-24 |
| K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland | Conmed Corporation | GEI | Class II | 2023-10-23 |
| K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) | Ansell Healthcare | KGO | Class I | 2023-10-20 |
| K232236 | Echo | Quanta System Spa | GEX | Class II | 2023-10-20 |
| K231749 | Radio Frequency System | Shenzhenshi Sincoheren S&T Development Co., Ltd. | GEI | Class II | 2023-10-19 |
| K232924 | T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. | FTL | Class II | 2023-10-18 |
| K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | Thi Total Healthcare Innovation GmbH | FXY | Class II | 2023-10-17 |
| K232903 | Legend X Platform | Pollogen, Ltd. | GEI | Class II | 2023-10-17 |
| K231495 | The Evolve System with the Transform Applicator | InMode , Ltd. | GEI | Class II | 2023-10-13 |
| K232809 | Cross Vascular RF Generator and Footswitch (optional accessory) | Cross Vascular, Inc. | GEI | Class II | 2023-10-12 |
| K230650 | Monopolar Electrode Surgical Instrument | Vhmed (Nantong) Co. , Ltd. | GEI | Class II | 2023-10-12 |
| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | FYA | Class II | 2023-10-12 |
| K232499 | IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) | Shenzhen Lescolton Electrical Appliance Co., Ltd. | OHT | Class II | 2023-10-11 |
| K232460 | Disposable electrosurgical pencil (MD1000) | Shenzhen Mecun Medical Supply Co., Ltd. | GEI | Class II | 2023-10-11 |
| K231603 | Standard Staple-Line Reinforcement (SSLR23) | Standard Bariatrics, Inc. | OXC | Class II | 2023-10-06 |
| K232407 | Cautery Protective Actuation System (CPAS) | Safer Surgeries Medical Devices, LLC | GEI | Class II | 2023-10-06 |
| K232056 | IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 | Dongguan Lide Electric Appliance Co., Ltd. | OHT | Class II | 2023-10-06 |
| DEN220087 | Edison System | HistoSonics, Inc. | QGM | Class II | 2023-10-06 |
| K230135 | Copioumed Chemotherapy Isolation Gown | Copioumed International, Inc. | FYC | Class II | 2023-10-04 |
| K232763 | Electrode Handpieces (VCT, RFTV, BMDT series) | RF Medical Co., Ltd. | GEI | Class II | 2023-10-04 |
| K232359 | Surgical face mask | Kingstar Medical (Xianning) Co., Ltd. | FXX | Class II | 2023-10-02 |
| K231628 | BeShape One Device | Beshape Technologies , Ltd. | OHV | Class II | 2023-09-29 |
| K231973 | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Ineo Tech Sdn Bhd | KGO | Class I | 2023-09-29 |
| K232274 | IPL hair removal device | Lumenessa Corp | OHT | Class II | 2023-09-28 |
| K231901 | Hakon, Hakon Smart | Medical San Indústria DE Equipamentos Médicos Ltda. | GEX | Class II | 2023-09-28 |
| K231971 | DEKA PHYSIQ 360 | El.En S.P.A. | PKT | Class II | 2023-09-26 |
| K231977 | PEACH 2, PEACH 2 Duo, PEACH 2 go | Foreo, Inc. | OHT | Class II | 2023-09-25 |
| K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | Coloplast | OTM | Class II | 2023-09-25 |
| K223919 | B.Light Clear Evo and B.Light Restore Evo | Bemer Int AG | OHS | Class II | 2023-09-23 |
| K231446 | Single-Use Latex Sterile Surgical Gloves (SG100) | Fitone Latex Products Co., Ltd. Guangdong | KGO | Class I | 2023-09-22 |
| K232183 | IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 | Shenzhen Koli Technology Co.,Ltd | OHT | Class II | 2023-09-22 |
| K231092 | T-SHAPE 2 | B&M S.R.L. Marketing Nel Benessere | NUV | Class II | 2023-09-22 |
| K230467 | BTL-899F | BTL Industries, Inc. | GEI | Class II | 2023-09-21 |
| K231894 | LED Spectrum therapy instrument | Shenzhenshi Sincoheren S&T Development Co., Ltd. | GEX | Class II | 2023-09-20 |
| K230966 | angiOCCLUDE Ligating Clips | A2 Medical Systems, LLC | FZP | Class II | 2023-09-19 |
| K231791 | PENTO Nd:YAG and Alexandrite laser system | Ilooda Co,., Ltd. | GEX | Class II | 2023-09-15 |
| K232146 | Anovo Pedestal | Momentis Surgical , Ltd. | QNM | Class II | 2023-09-14 |
| K232124 | IPL Hair Removal, Model: W-1095, W-1098 | Shenzhen Wochuan Electronic Co., Ltd. | OHT | Class II | 2023-09-14 |
| K230746 | Non absorbable Surgical Polypropylene Suture | Shandong Haidike Medical Products Co., Ltd. | GAW | Class II | 2023-09-14 |
| K232192 | Venus Versa PRO System | Venus Concept, Inc. | ONF | Class II | 2023-09-11 |
| K230362 | Planar LED mate | Shenzhen Leaflife Technology Co., Ltd. | OHT | Class II | 2023-09-11 |
| K231146 | AliTight | Alic Iotech, LLC | GEI | Class II | 2023-09-08 |
| K230310 | STAT Medical Device Lancing System | Stat Medical Devices | QRK | Class II | 2023-09-08 |
| K230535 | KARL STORZ Urological Laser Accessories | Karl Storz SE & CO. KG | GEX | Class II | 2023-09-08 |
| K221743 | Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes | Jiangsu Bonss Medical Technology Co., Ltd. | GEI | Class II | 2023-09-07 |
| K231800 | IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 | Shenzhen Qianyu Technology Co., Ltd. | OHT | Class II | 2023-09-07 |
| K231717 | IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 | Foshan Jindi Electric Appliance Co., Ltd. | OHT | Class II | 2023-09-06 |
| K231710 | OW100S | Softwave/Trt, LLC | PZL | Class II | 2023-09-01 |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. | KGO | Class I | 2023-08-31 |
| K223303 | Spinery RF Ablation System | Axon Spine Medical System | GEI | Class II | 2023-08-30 |
| K230013 | Silk'n Titan Allways | Silk'N Beauty , Ltd. | PAY | Class II | 2023-08-30 |
| K232295 | LAA Exclusion System | Syntheon, LLC | PZX | Class II | 2023-08-30 |
| K231024 | AquaBeam Robotic System | Procept Biorobotics, Corporation | PZP | Class II | 2023-08-30 |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) | Ethicon Endo Surgery, LLC | FZP | Class II | 2023-08-29 |
| K231537 | SofWave System | Sofwave Medical, Ltd. | OHV | Class II | 2023-08-28 |
| K223727 | Lavieen | Wontech Co., Ltd. | GEX | Class II | 2023-08-25 |
| K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | GAT | Class II | 2023-08-25 |
| K231872 | Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) | Kirwan Surgical Products, LLC | GEI | Class II | 2023-08-25 |
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | Ansell Healthcare Products, LLC | KGO | Class I | 2023-08-23 |
| K230610 | Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) | Dongguan Shin YI Healthcare Products Factory | FYA | Class II | 2023-08-23 |
| K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | Xiantao Zhibo Non-Woven Products Co., Ltd. | FYA | Class II | 2023-08-22 |
| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | Olympus Winter & Ibe GmbH | GEI | Class II | 2023-08-18 |
| K222993 | Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs | Sentienx Sdn Bhd | KGO | Class I | 2023-08-18 |
| K232153 | Avéli | Revelle Aesthetics, Inc. | OUP | Class II | 2023-08-18 |
| K231718 | Holmium Medical Laser | Allengers Global Healthcare Private Limited | GEX | Class II | 2023-08-18 |
| K223538 | Integrity Implant | Anika Therapeutics, Inc. | OWX | Class II | 2023-08-17 |
| K230577 | Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi | FYA | Class II | 2023-08-16 |
| K230832 | Powdered Free Sterile Natural Rubber Latex Surgical Gloves | The Egyptian Company For Medical & Electronic Industries | KGO | Class I | 2023-08-16 |
| K230342 | Phototherapy System (OL-PDT950) | Shanghai Omni Laser Skinology Co., Ltd. | GEX | Class II | 2023-08-16 |
| K230663 | Density | Jeisys Medical, Inc. | GEI | Class II | 2023-08-14 |
| K231054 | V-Laser | Wontech Co., Ltd. | GEX | Class II | 2023-08-14 |
| K230420 | Dr. pen Microneedling System | Guangzhou Ekai Electronic Technology Co., Ltd. | QAI | Class II | 2023-08-11 |
| K230384 | PolyWear® Personal Protective Level 3 Gown | PolyConversions, Inc. | QPC | Class II | 2023-08-11 |
| K223856 | NuEra Tight RF Family | Bios S.R.L. | GEI | Class II | 2023-08-11 |
| K230268 | ZenPro 40 | BLUECORE COMPANY Co., Ltd. | GEX | Class II | 2023-08-10 |
| K223500 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | GAT | Class II | 2023-08-10 |
| K231394 | Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. | ONF | Class II | 2023-08-09 |
| K230304 | Polyisoprene Surgical Gloves | Puyang Linshi Medical Supplies Co., Ltd. | KGO | Class I | 2023-08-09 |
| K222128 | Protective Gown AAMI Level 4 | Kenpax International Limited | QPC | Class II | 2023-08-08 |
| K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | GEH | Class II | 2023-08-08 |
| K223673 | Surgeon Controlled Arm | Levita Magnetics International Corp | PNL | Class II | 2023-08-04 |
| K230380 | Surgical Face Masks, Model: EFMDS-L50Pn BLU | Iris USA | FXX | Class II | 2023-08-03 |
| K231548 | Medical Diode Laser, Model S1Pro | Wuhan Pioon Technology Co., Ltd. | GEX | Class II | 2023-08-03 |
| K223122 | MENIX®; MENIX® DUO | S.B.M. Sas (Science & Bio Materials) | GAT | Class II | 2023-08-03 |
| K231126 | Eblator Device | E Surgical, LLC | GEI | Class II | 2023-08-02 |
| K231613 | Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. | Zhuzhou Goldenhot Medical Technology Co., Ltd. | OHT | Class II | 2023-07-31 |
| K221767 | Surgical Sutures with or without Needle | Huaian Seamen Medical Technology Co., Ltd. | GAP | Class II | 2023-07-31 |
| K222862 | SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC | Lotuxs Medtech (Suzhou) Co., Ltd. | GEX | Class II | 2023-07-30 |
| K230898 | FLUOBEAM® LX Red | Fluoptics Sas | QDG | Class II | 2023-07-28 |
| K231618 | 3 Layer Surgical Mask (134252531) | Original Mattress Factory, Inc. | FXX | Class II | 2023-07-28 |
| K231073 | SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Esthetic Medical, Inc. | QAI | Class II | 2023-07-28 |
| K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets | Cardinal Health200, LLC | FYA | Class II | 2023-07-27 |
| K231555 | LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) | iSMART Developments, Ltd. | OHS | Class II | 2023-07-27 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.