| Coolfase (K250852) | Asterasys Co., Ltd. | 2025-10-16 |
| TargetCool-e (K253348) | Recensmedical, Inc. | 2025-10-15 |
| InbellaMulti System (K252367) | Inbella Medical, Inc. | 2025-10-15 |
| V-soft Line™ Barbed Surgical Suture (Various) (K250107) | Feeltech Co., Ltd. | 2025-10-15 |
| Lithoblast Single Use Holmium Laser Fibers (K250776) | Dawell Medical, LLC | 2025-10-14 |
| 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) (K252234) | Shenzhen Qiaochengli Technology Co., Ltd. | 2025-10-14 |
| GENEO X ELITE (K242227) | Pollogen, Ltd. | 2025-10-12 |
| IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) (K252209) | Foshan Jindi Electric Appliance Co., Ltd. | 2025-10-10 |
| Verruca-Freeze H Plus (K252903) | Cryosurgery, Inc. | 2025-10-10 |
| HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (K251082) | Procept Biorobotics | 2025-10-10 |
| ORA Method LED Gua Sha (GS-04) (K252272) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-10-09 |
| The Botticelli (Model: Athena) (K251699) | Bellamia Technologies, Inc. | 2025-10-08 |
| 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) (K252150) | Olympus Medical Systems Corporation | 2025-10-07 |
| Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) (K250688) | Acotec Scientific Co., Ltd. | 2025-10-07 |
| HESTIA (L200-A) (K242946) | Senbitec Co., Ltd. | 2025-10-03 |
| TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) (K251464) | Jeisys Medical Incorporated | 2025-10-03 |
| ProSense™ System (DEN220077) | Icecure Medical | 2025-10-03 |
| PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) (K252820) | Internacional Farmacéutica S.A DE C.V | 2025-10-03 |
| extriCARE® 1000 Negative Pressure Wound Therapy System (K251646) | Alleva Medical Devices | 2025-10-03 |
| IPL Hair Removal Device (IPL-001, IPL-002) (K251398) | Shenzhen Enmind Technology Co., Ltd. | 2025-10-02 |
| Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) (K251825) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-10-01 |
| Light Therapy Decollete Mask (1019135) (K252096) | Merchsource, LLC | 2025-10-01 |
| E Blator (K251899) | New Deantronics Taiwan , Ltd. | 2025-10-01 |
| 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, (K252804) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-10-01 |
| Picosecond laser device (BMPS4) (K252447) | Hebei Newangie Technology Co., Ltd. | 2025-10-01 |
| Dexter L6 System (K251197) | Distalmotion SA | 2025-09-30 |
| Arthrex SpeedFLEX™ Implant (K251690) | Arthrex, Inc. | 2025-09-30 |
| NEW DOUBLO 2.0 (K251334) | Hironic Co., Ltd. | 2025-09-29 |
| Thulium Laser System (Deluxlase) (K251919) | Nanjing Bestview Laser S&T Co., Ltd. | 2025-09-26 |
| Magnetic Surgical System (K252435) | Levita Magnetics International Corp | 2025-09-26 |
| Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (K252063) | Wuhan Dimed Laser Technology Co., Ltd. | 2025-09-25 |
| Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories (K250071) | Alma Lasers, Inc. | 2025-09-24 |
| PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture (K252644) | M/s. Meril Endo Surgery Private Limited. | 2025-09-23 |
| Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) (K252043) | Olympus Winter & Ibe GmbH | 2025-09-23 |
| Luminance Red Cold Sore Device (TN1927G) (K251973) | Luminance Medical Ventures, Inc. | 2025-09-23 |
| Tapestry Biointegrative Implant (K252647) | Embody, Inc. | 2025-09-19 |
| IPGTFL-02 (K251100) | Ipg Medical Corporation | 2025-09-19 |
| VEGA (K242859) | Ibramed Equipamentos Médicos | 2025-09-19 |
| BondEase 2 Topical Skin Adhesive (K243990) | Optmed, Inc. | 2025-09-19 |
| Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) (K251902) | Vitacore Industries, Inc. | 2025-09-17 |
| IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) (K251914) | Miley Technology (Hebei) Co., Ltd. | 2025-09-15 |
| Legend X Platform (K252576) | Pollogen, Ltd. | 2025-09-12 |
| Erchonia EVRL (K251843) | Erchonia Corporation | 2025-09-12 |
| LED Light Therapy Mask (2311, 2344, 2457, 2458) (K252189) | Dongguan Yanxi Technology Co., Ltd. | 2025-09-12 |
| PowerKnot High Strength Sutures (K252225) | Medacta International S.A. | 2025-09-12 |
| RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (K251826) | Smith & Nephew Medical, Ltd. | 2025-09-11 |
| OptiLUV Device (K250734) | Pollogen, Ltd. | 2025-09-10 |
| PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (K250483) | Stryker Instruments | 2025-09-09 |
| Symani Surgical System (K251510) | Medical Microinstruments, Inc. | 2025-09-04 |
| KALA MINI 2.0 (KALA-04) (K251781) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-09-04 |
| Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) (K251298) | Clinical Laserthermia Systems, AB | 2025-09-04 |
| Intense Pulsed Light Therapy Device (MMABM-1) (K251545) | Micowey Medical Equipment (Guangxi) Co., Ltd. | 2025-09-04 |
| Diode laser therapy device (VADER) (K251457) | Beijing Superlaser Technology Co., Ltd. | 2025-09-03 |
| AGNES Ultra (K250217) | Agnes Medical Co., Ltd. | 2025-09-03 |
| MEDILIGHT (K231952) | Medicreations, LLC | 2025-09-03 |
| Erbe ESU Model VIO® 3n with Accessories (K251108) | Erbe Elektromedizin GmbH | 2025-08-29 |
| GLAM LED Facial Mask (TB-2386F) (K251727) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2025-08-29 |
| Heager Medical Laser Family (Sabrina/Adolf) (K250261) | Heager GmbH | 2025-08-26 |
| PRO Pen Microneedling System (6883) (K243800) | Dermalogica, LLC | 2025-08-25 |
| LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (K251588) | Shenzhen Fittop Health Technology Co., Ltd. | 2025-08-21 |
| Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid (K250313) | Harps Europe Manufacturing GmbH | 2025-08-19 |
| Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) (K252316) | Venclose, Inc. | 2025-08-19 |
| Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) (K243713) | Agnes Medical Co., Ltd. | 2025-08-19 |
| FEATHER 01 02 03 04 (Model:01) (K251871) | Heat IN A Click, LLC | 2025-08-15 |
| IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) (K251176) | Shenzhen Mlay Intelligent Technology Co., , Ltd. | 2025-08-14 |
| WinForth (LM-E470KA) (K250916) | Shenzhen Leaflife Technology Co., Ltd. | 2025-08-14 |
| TRUDERMAL Pro (ZLD-390) (K251012) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-08-14 |
| HS Fiber (K252201) | Riverpoint Medical | 2025-08-13 |
| DOLORCLAST Focused Shock Waves (K243279) | E.M.S Electro Medical Systems S.A | 2025-08-13 |
| HOTWIRE™ System RF Generator and Footswitch (optional accessory) (K252083) | Atraverse Medical, Inc. | 2025-08-12 |
| XERF (K251327) | Lutronic Corporation | 2025-08-11 |
| Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) (K252211) | Cnc Technologies | 2025-08-11 |
| Diode laser device (BM091) (K251801) | Hebei Newangie Technology Co., Ltd. | 2025-08-08 |
| swiftPro System (SWF-SPS); Swift System (SWF-SYS) (K250718) | Emblation Limited | 2025-08-08 |
| LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) (K251667) | Shenzhen Liyoutong Technology Co., Ltd. | 2025-08-07 |
| Olo (K251432) | El.En S.P.A. | 2025-08-06 |
| CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) (K250950) | Okapi Medical, LLC Dba Resivant Medical | 2025-08-04 |
| IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) (K251707) | Shenzhen Huachuangtong Industrial Co., Ltd. | 2025-08-01 |
| Self-Forming Magnet (Flexagon Plus OTOLoc) (K250541) | GI Windows, Inc. | 2025-08-01 |
| eCO2 3D (K244060) | Lutronic Corporation | 2025-07-31 |
| Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) (K251076) | Shenzhen Lifotronic Technology Co., Ltd. | 2025-07-30 |
| Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) (K251339) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-07-25 |
| InbellaMAX System (K252215) | Inbella Medical , Ltd. | 2025-07-25 |
| Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) (K251984) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-07-24 |
| Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (K252056) | AtriCure, Inc. | 2025-07-24 |
| Onflex™ Mesh (K251955) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2025-07-24 |
| MammoSTAR Biopsy Site Identifier (K251748) | Carbon Medical Technologies, Inc. | 2025-07-23 |
| Resilience Fully Covered Esophageal Stent System (K251265) | Merit Medical Systems, Inc. | 2025-07-23 |
| LymphaTech Mobile 3D Measuring Tool (K251255) | Lymphatech, Inc. | 2025-07-22 |
| VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (K251655) | Alafair Biosciences | 2025-07-18 |
| Jewel Soft Tissue Reinforcement Device (102-6005) (K242237) | Xiros Limited | 2025-07-15 |
| Kerecis SurgiBind (50241) (K251844) | Kerecis Limited | 2025-07-15 |
| Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) (K251173) | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025-07-14 |
| Leonardo Duster (K250504) | Ceramoptec GmbH | 2025-07-14 |
| KALA Therapy Wand (Model: KALA-03) (K250761) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-07-11 |
| AviClear Laser System (K251149) | Cutera, Inc. | 2025-07-11 |
| Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) (K250942) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-07-11 |
| Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers (K251759) | Boston Scientific Corporation | 2025-07-09 |
| DENSITY; DENZA; DENSITY Noir (K250065) | Jeisys Medical Incorporated | 2025-07-08 |
| Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (K251761) | Momentis Surgical , Ltd. | 2025-07-08 |