Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 39
- Latest Decision
- 2024-05-13
Clearances · page 10 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K240658 | 1060nm laser body slimming machine | Hebei JT Medical Co., Ltd. | PKT | Class II | 2024-05-13 |
| K234079 | HyperSuture Extension Line | Threadstone, LLC | GAT | Class II | 2024-05-10 |
| K233918 | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory | PEM | Class II | 2024-05-09 |
| K233803 | UltraClear Laser System (N/A) | Acclaro Corporation | GEX | Class II | 2024-05-08 |
| K241008 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027) | Relign Corporation, Subsidiary of Zimmer Biomet | GEI | Class II | 2024-05-08 |
| K240964 | FLOW 90? Wand | ArthroCare Corporation | GEI | Class II | 2024-05-08 |
| K240999 | Legend X Applicator VO | Pollogen, Ltd. | GEI | Class II | 2024-05-08 |
| K233766 | Geneo X Elite | Pollogen, Ltd. | PAY | Class II | 2024-05-07 |
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | Innovaquartz, LLC | GEX | Class II | 2024-05-03 |
| K240297 | Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) | Us Medical Innovations, LLC | OAB | Class II | 2024-05-03 |
| K240185 | Cypris eXact Suture Placement Device | Cypris Medical | GEJ | Class I | 2024-05-03 |
| K232858 | ORskin Blue | Megabay S.A. | GEX | Class II | 2024-05-01 |
| K240118 | Picosecond Nd:YAG Laser System | Smedtrum Medical Technology Co., Ltd. | GEX | Class II | 2024-04-30 |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | ESW | Class II | 2024-04-29 |
| K240248 | Volnewmer | Classys, Inc. | GEI | Class II | 2024-04-29 |
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | Surgical Instrument Service and Savings, Inc. | NUJ | Class II | 2024-04-29 |
| K232805 | Kronos Electrocautery Device | Single Pass, Inc. | GEI | Class II | 2024-04-25 |
| K232246 | 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. | NEW | Class II | 2024-04-25 |
| K240093 | IPL Home Use Hair Removal Device (SJ15) | Shenzhen Shuge Medical Beauty Devices Co., Ltd. | OHT | Class II | 2024-04-24 |
| K222958 | mJOULE RF System and Accessories | Sciton, Inc | GEI | Class II | 2024-04-23 |
| K234147 | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) | Microline Surgical, Inc. | GEI | Class II | 2024-04-23 |
| K233849 | BTL-499 | BTL Industries, Inc. | GEI | Class II | 2024-04-23 |
| K240816 | MeDioStar | Asclepion Laser Technologies GmbH | GEX | Class II | 2024-04-23 |
| K240518 | swiftPro System | Emblation Limited | NEY | Class II | 2024-04-23 |
| K240378 | FAQ 201, FAQ 202 | Foreo, Inc. | OHS | Class II | 2024-04-19 |
| K240258 | Disposable Medical Face Mask (M643BE) | Makrite Industries, Inc. | FXX | Class II | 2024-04-18 |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. | OMP | Class II | 2024-04-18 |
| K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | OMP | Class II | 2024-04-17 |
| K233962 | ReBorn (1050nm) | Lightfective , Ltd. | PKT | Class II | 2024-04-16 |
| K232133 | Co2 Laser System, Models: PureLase And VanLase | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | GEX | Class II | 2024-04-16 |
| K233757 | TitanPico Laser Workstation (PICO-450) | Rhein Laser Technologies Co., Ltd. | GEX | Class II | 2024-04-11 |
| K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2024-04-10 |
| K234057 | NIRVANA | El.En S.P.A. | GEX | Class II | 2024-04-10 |
| K233789 | 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation | FYD | Class II | 2024-04-10 |
| K233999 | GalaFLEX LITE Scaffold | Tepha, Inc. | OOD | Class II | 2024-04-09 |
| K240360 | Wrinkle Treatment Device (JM2) | Shenzhen Qianyu Technology Co., Ltd. | OHS | Class II | 2024-04-05 |
| DEN230032 | Symani Surgical System | Mmi North America, Inc. | SAQ | Class II | 2024-04-05 |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | ESW | Class II | 2024-04-04 |
| K240071 | Peleton Universal Single Use Power System and Attachments | Peleton Surgical | SAM | Class I | 2024-04-04 |
| K240652 | Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2024-04-04 |
| K240282 | IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) | Dongguan Boyuan Intelligent Technology Co.,Ltd | OHT | Class II | 2024-04-03 |
| K232112 | R&G Surgical Mask | R&G Seguridad E Higiene Industrial S.A.C. | FXX | Class II | 2024-04-02 |
| K240587 | SmoothSkin Pure Unplugged (SSB3) | Cyden Limited | OHT | Class II | 2024-03-29 |
| K233068 | Disposable Surgical Gown | Nanning Tecbod Biological Technology Co., Ltd. | FYA | Class II | 2024-03-29 |
| K233604 | BTL-785S | BTL Industries, Inc. | GEI | Class II | 2024-03-28 |
| K232079 | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. | KGO | Class I | 2024-03-28 |
| K233838 | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B) | Medtronic, Inc. | NEY | Class II | 2024-03-28 |
| DEN210049 | Medline ART Skin Harvesting System | Medline Industries, Inc. | QYK | Class II | 2024-03-27 |
| K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) | Hyundae Meditech Co., Ltd. | NEW | Class II | 2024-03-27 |
| K234085 | LUNE PureHygiene | Enamel Pure | GEX | Class II | 2024-03-25 |
| K240522 | Esophageal TTS Stent | Taewoong Medical | ESW | Class II | 2024-03-22 |
| K234081 | RedDrop ONE (One) | Reddrop DX | FMK | Class II | 2024-03-21 |
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories | Ipg Medical Corporation | GEX | Class II | 2024-03-21 |
| K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | GEX | Class II | 2024-03-21 |
| K233002 | BEED 2,5, BEED 3,8 | Excelsior Resources, LLC | GEI | Class II | 2024-03-20 |
| K233642 | InMode RF System | InMode , Ltd. | GEI | Class II | 2024-03-20 |
| K240537 | SMARTXIDE PRO | El.En S.P.A. | GEX | Class II | 2024-03-20 |
| K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) | Shenzhen Desida Technology Co., Ltd. | BTA | Class II | 2024-03-20 |
| K231719 | Medical Surgical Mask | Azur Medical Company, Inc. | FXX | Class II | 2024-03-19 |
| K230981 | Meriglu Topical Skin Adhesive | M/s. Meril Endo Surgery Private Limited. | MPN | Class II | 2024-03-16 |
| K233307 | Intensity Pulsed Light Therapy System | Beijing Adss Development Co., Ltd. | ONF | Class II | 2024-03-15 |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser) | Wontech Co., Ltd. | GEX | Class II | 2024-03-15 |
| K232301 | Define RF Microneedling System | Aesthetic Management Partners | GEI | Class II | 2024-03-14 |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Boston Scientific | GEH | Class II | 2024-03-13 |
| K233466 | Edison System | HistoSonics, Inc. | QGM | Class II | 2024-03-13 |
| K240497 | Smartxide Tetra Pro | El.En S.P.A. | GEX | Class II | 2024-03-12 |
| K240132 | EmoLED (v. 2-USA) | Emoled, Srl | GEX | Class II | 2024-03-12 |
| K240264 | Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) | Shenzhen Mlay Intelligent Technology Co., , Ltd. | OHT | Class II | 2024-03-08 |
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | MQR | Class II | 2024-03-08 |
| K240396 | Elite iQ PRO (M122K1) | Cynosure, LLC | GEX | Class II | 2024-03-08 |
| K233705 | CellFX Percutaneous Electrode System (SYS3000) | Pulse Biosciences, Inc. | GEI | Class II | 2024-03-08 |
| K232424 | CurrentBody Skin RF | El Global Trade, Ltd. | PAY | Class II | 2024-03-06 |
| K232703 | Disposable Bipolar Forceps | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | GEI | Class II | 2024-03-06 |
| K233526 | Medline Open-back Level 3 Protective Gown | Medline Industries, LP | QPC | Class II | 2024-03-05 |
| K230047 | Medical Diode Laser Systems | Gigaalaser Company , Ltd. | NVK | Class II | 2024-03-04 |
| K233862 | NUNA LUX (NUNL528) | Premier North America, Inc. | OHS | Class II | 2024-03-01 |
| K230837 | PlazMagik | Agnes Medical Co., Ltd. | GEI | Class II | 2024-02-29 |
| K240244 | NPseal (Small, Medium, Large) | Guard Medical, Inc. | OKO | Class II | 2024-02-29 |
| K232885 | Dawn Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | NVK | Class II | 2024-02-28 |
| K233830 | OsteoCool 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | GEI | Class II | 2024-02-28 |
| K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) | Maquet Cardiovascular, LLC | GEI | Class II | 2024-02-27 |
| DEN230025 | MIRA Surgical System | Virtual Incision | SAB | Class II | 2024-02-23 |
| K233709 | Exceed Unlimited | Mt. Derm GmbH | QAI | Class II | 2024-02-23 |
| K231876 | MultiPulse HoPLUS | Asclepion Laser Technologies GmbH | GEX | Class II | 2024-02-22 |
| K232831 | Quiver Aspiration Pump | Anoxia Medical, Inc. | BTA | Class II | 2024-02-22 |
| K240313 | Oligio X | Wontech Co., Ltd. | GEI | Class II | 2024-02-22 |
| K223826 | NanoDrop Lancet | Drawbridge Health, Inc. | FMK | Class II | 2024-02-22 |
| K233996 | Ulthera System (UC-1 Control Unit PRIME) | Ulthera, Inc. | OHV | Class II | 2024-02-22 |
| K233760 | Mjolnir Pro. (Multielectrode plasma) | Shenzhen Leaflife Technology Co., Ltd. | QVJ | Class II | 2024-02-20 |
| K231896 | Diode Laser Therapy System | Beijing Adss Development Co., Ltd. | GEX | Class II | 2024-02-20 |
| K231985 | Disposable Grounding Pad | Shenzhen Mecun Medical Supply Co., Ltd. | GEI | Class II | 2024-02-16 |
| K231514 | Azure | Daeshin Enterprise Co., Ltd. | GEX | Class II | 2024-02-14 |
| K233661 | Transorb Self-Gripping Resorbable Mesh | Sofradim Production | OWT | Class II | 2024-02-13 |
| K231468 | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | NEU | Class II | 2024-02-12 |
| K232072 | AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G | H.S Hospital Service S.P.A | GEI | Class II | 2024-02-09 |
| K233024 | Alma Harmony | Alma Lasers, Inc. | GEX | Class II | 2024-02-08 |
| K233416 | Cryojet Plus (SHE-ACP001-1) | Beijing Sano Laser S&T Development Co.,Ltd | GEX | Class II | 2024-02-06 |
| K232379 | PREVENT Kit | Clear Choice Therapeutics | OMP | Class II | 2024-02-05 |
| K233756 | Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) | Rhein Laser Technologies Co., Ltd. | GEX | Class II | 2024-02-02 |
| K233143 | PiXel8-Reveal | Rohrer Aesthetics | GEX | Class II | 2024-02-02 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.