Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 31
- Latest Decision
- 2025-12-09
Clearances · page 4 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | GEH | Class II | 2025-12-09 |
| K252994 | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) | Guangdong Ace-Tec Co., Ltd. | OHS | Class II | 2025-12-08 |
| K252142 | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | OHS | Class II | 2025-12-05 |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | FYA | Class II | 2025-12-03 |
| K250725 | Hugo RAS System | Covidien, LLC | SCV | Class II | 2025-12-03 |
| K252786 | Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited. | OLI | Class II | 2025-12-01 |
| K252658 | Medical Diode Laser Systems (TR-B) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | GEX | Class II | 2025-11-28 |
| K253303 | Dendrite Imaging System | Dendrite Imaging, Inc. | QDG | Class II | 2025-11-28 |
| K253344 | BELLUS-Q | Speclipse, Inc. | GEX | Class II | 2025-11-25 |
| K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited | PMC | Class II | 2025-11-25 |
| K253219 | LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. | GEX | Class II | 2025-11-25 |
| K253304 | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) | Dongguan Lide Electric Appliance Co., Ltd. | OHT | Class II | 2025-11-25 |
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | F Care Systems USA, LLC | GEI | Class II | 2025-11-24 |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | GEX | Class II | 2025-11-24 |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | GEX | Class II | 2025-11-24 |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. | OMP | Class II | 2025-11-21 |
| K253123 | CuRAS hybrid | Classys, Inc. | GEX | Class II | 2025-11-20 |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | GEX | Class II | 2025-11-20 |
| K250643 | Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. | FZP | Class II | 2025-11-20 |
| K252642 | Microcurrent Facial Device (CEC101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | OHS | Class II | 2025-11-19 |
| K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | Sunglor Technology Co., Ltd. | OHS | Class II | 2025-11-19 |
| K253035 | IPL Hair Removal Device (SYL001AZ, SYL002AZ) | Gu'An Yeolight Smart Electronics Co., Ltd. | OHT | Class II | 2025-11-19 |
| K251566 | TS-RF Generator (STS10) | Starmed Co., Ltd. | GEI | Class II | 2025-11-17 |
| K252618 | IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | Alovea Healthcare Co. , Ltd. | OHT | Class II | 2025-11-14 |
| K252308 | LED Beauty Mask (RLBXX) | Atop Lighting Co., Ltd. | OHS | Class II | 2025-11-13 |
| K253290 | XSTAT P15 | Revmedx, Inc. | PGZ | Class II | 2025-11-12 |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | NEW | Class II | 2025-11-12 |
| K252287 | Symani Surgical System | Medical Microinstruments, Inc. | SAQ | Class II | 2025-11-10 |
| K252519 | CO2 Laser Therapy System (K106) | Hebei Keylaser Sci-Tech Co.,Ltd | GEX | Class II | 2025-11-07 |
| K252564 | Medical Diode Laser Systems (VeinCure) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | GEX | Class II | 2025-11-07 |
| K252515 | Q-Switched Nd:Yag laser (K690) | Hebei Keylaser Sci-Tech Co.,Ltd | GEX | Class II | 2025-11-06 |
| K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | GEI | Class II | 2025-11-06 |
| K251303 | Tamburo Thulium Fiber Laser System | Menovex Medical Technology (Shenzhen) Co., Ltd. | GEX | Class II | 2025-11-04 |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp. | GEI | Class II | 2025-11-04 |
| K252964 | PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. | FXX | Class II | 2025-11-04 |
| K252427 | Diode Laser Hair Removal Machine (GLD01) | Sanhe Meditech Co., Ltd. | GEX | Class II | 2025-10-31 |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources Corporation | GEI | Class II | 2025-10-31 |
| K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | Boston Scientific Corporation | GEX | Class II | 2025-10-30 |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | ESW | Class II | 2025-10-30 |
| K253327 | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | ESW | Class II | 2025-10-30 |
| K252752 | ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. | QAI | Class II | 2025-10-30 |
| K253153 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | QAI | Class II | 2025-10-29 |
| K250275 | PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | Baylis Medical Technologies, Inc. | GEI | Class II | 2025-10-28 |
| K252053 | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | OHS | Class II | 2025-10-27 |
| K251824 | Patriot Duo | Patriot Laser, LLC | GEX | Class II | 2025-10-27 |
| K253125 | Parietene Flat Sheet Mesh | Medtronic - Sofradim Production | FTL | Class II | 2025-10-24 |
| K252345 | Picosecond Laser Device (PF131-BI) | Risu Medical Technology Co., Ltd. | GEX | Class II | 2025-10-23 |
| K253100 | MultiPulse TFL | Asclepion Laser Technologies GmbH | GEX | Class II | 2025-10-23 |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2025-10-23 |
| K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | GAT | Class II | 2025-10-22 |
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. | GEI | Class II | 2025-10-21 |
| K252155 | AVAVA Skin Treatment System | AVAVA, Inc. | ONG | Class II | 2025-10-20 |
| K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. | GEX | Class II | 2025-10-20 |
| K251414 | Miracu Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | NEW | Class II | 2025-10-20 |
| K252264 | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) | Shenzhen Zhenxing Ruitong Technology Co., Ltd. | OHS | Class II | 2025-10-17 |
| K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | GEH | Class II | 2025-10-16 |
| K253114 | TargetCool (RM-DT02W) | Recensmedical, Inc. | GEH | Class II | 2025-10-16 |
| K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30) | Matelaser, Inc. | NVK | Class II | 2025-10-16 |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | GAT | Class II | 2025-10-16 |
| K250852 | Coolfase | Asterasys Co., Ltd. | GEI | Class II | 2025-10-16 |
| K252093 | Light Therapy Mask (1019055) | Merchsource, LLC | OHS | Class II | 2025-10-16 |
| K250107 | V-soft Line Barbed Surgical Suture (Various) | Feeltech Co., Ltd. | NEW | Class II | 2025-10-15 |
| K253348 | TargetCool-e | Recensmedical, Inc. | GEH | Class II | 2025-10-15 |
| K252367 | InbellaMulti System | Inbella Medical, Inc. | GEI | Class II | 2025-10-15 |
| K250776 | Lithoblast Single Use Holmium Laser Fibers | Dawell Medical, LLC | GEX | Class II | 2025-10-14 |
| K252234 | IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) | Shenzhen Qiaochengli Technology Co., Ltd. | OHT | Class II | 2025-10-14 |
| K242227 | GENEO X ELITE | Pollogen, Ltd. | PAY | Class II | 2025-10-12 |
| K252209 | IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) | Foshan Jindi Electric Appliance Co., Ltd. | OHT | Class II | 2025-10-10 |
| K252903 | Verruca-Freeze H Plus | Cryosurgery, Inc. | GEH | Class II | 2025-10-10 |
| K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | Procept Biorobotics | PZP | Class II | 2025-10-10 |
| K252272 | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2025-10-09 |
| K251699 | The Botticelli (Model: Athena) | Bellamia Technologies, Inc. | GEX | Class II | 2025-10-08 |
| K250688 | Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) | Acotec Scientific Co., Ltd. | GEI | Class II | 2025-10-07 |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) | Olympus Medical Systems Corporation | GEI | Class II | 2025-10-07 |
| DEN220077 | ProSense System | Icecure Medical | QXW | Class II | 2025-10-03 |
| K242946 | HESTIA (L200-A) | Senbitec Co., Ltd. | GEX | Class II | 2025-10-03 |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | OMP | Class II | 2025-10-03 |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) | Internacional Farmacéutica S.A DE C.V | GAM | Class II | 2025-10-03 |
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) | Jeisys Medical Incorporated | GEX | Class II | 2025-10-03 |
| K251398 | IPL Hair Removal Device (IPL-001, IPL-002) | Shenzhen Enmind Technology Co., Ltd. | OHT | Class II | 2025-10-02 |
| K251899 | E Blator | New Deantronics Taiwan , Ltd. | GEI | Class II | 2025-10-01 |
| K252804 | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2025-10-01 |
| K252447 | Picosecond laser device (BMPS4) | Hebei Newangie Technology Co., Ltd. | GEX | Class II | 2025-10-01 |
| K252096 | Light Therapy Decollete Mask (1019135) | Merchsource, LLC | OHS | Class II | 2025-10-01 |
| K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHS | Class II | 2025-10-01 |
| K251690 | Arthrex SpeedFLEX Implant | Arthrex, Inc. | OWY | Class II | 2025-09-30 |
| K251197 | Dexter L6 System | Distalmotion SA | SDD | Class II | 2025-09-30 |
| K251334 | NEW DOUBLO 2.0 | Hironic Co., Ltd. | GEI | Class II | 2025-09-29 |
| K251919 | Thulium Laser System (Deluxlase) | Nanjing Bestview Laser S&T Co., Ltd. | GEX | Class II | 2025-09-26 |
| K252435 | Magnetic Surgical System | Levita Magnetics International Corp | PNL | Class II | 2025-09-26 |
| K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) | Wuhan Dimed Laser Technology Co., Ltd. | GEX | Class II | 2025-09-25 |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories | Alma Lasers, Inc. | GEX | Class II | 2025-09-24 |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | Olympus Winter & Ibe GmbH | GEI | Class II | 2025-09-23 |
| K251973 | Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. | OKJ | Class II | 2025-09-23 |
| K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. | NEW | Class II | 2025-09-23 |
| K243990 | BondEase 2 Topical Skin Adhesive | Optmed, Inc. | MPN | Class II | 2025-09-19 |
| K251100 | IPGTFL-02 | Ipg Medical Corporation | GEX | Class II | 2025-09-19 |
| K242859 | VEGA | Ibramed Equipamentos Médicos | GEX | Class II | 2025-09-19 |
| K252647 | Tapestry Biointegrative Implant | Embody, Inc. | OWY | Class II | 2025-09-19 |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) | Vitacore Industries, Inc. | FXX | Class II | 2025-09-17 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.