| SOLIUS PRO UVB Light Panel (K252960) | Solius Labs, Inc. | 2026-01-16 |
| Ignite RF System (K251254) | InMode , Ltd. | 2026-01-15 |
| ENTire IRE System (K251996) | Entire Medical , Ltd. | 2026-01-14 |
| Dr. Yglo Skin Tag Remover (K251524) | Theotclab Healthcare B.V. | 2026-01-12 |
| Disposable Surgical Face Mask (3P00B, C2900) (K252830) | Beatles Medical Supplies (Xiantao) Co., Ltd. | 2026-01-12 |
| Boston iFace (Boston iFace) (K251988) | Boston Aesthetics, Inc. | 2026-01-12 |
| ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (K252906) | Ethicon Endo-Surgery, LLC | 2026-01-09 |
| Self-Forming Magnet (Flexagon Plus OTOLoc) (K253550) | GI Windows, Inc. | 2026-01-09 |
| PuraStat (K253924) | 3-D Matrix Europe SAS | 2026-01-07 |
| Sensilift Pro (ST300XXYYZZZ) (K250341) | El Global Trade, Ltd. | 2026-01-06 |
| Disposable Medical Face Mask (K252650) | Makrite Industries, Inc. | 2026-01-05 |
| FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit (K253867) | ZuriMED Technologies AG | 2026-01-02 |
| MOLLI 2 System (K253888) | Stryker Endoscopy | 2025-12-31 |
| Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) (K253881) | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025-12-29 |
| Feather/numiere 05 06 07 (05) (K253279) | Heat IN A Click, LLC | 2025-12-24 |
| PICO-K (K253342) | Speclipse, Inc. | 2025-12-24 |
| LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) (K253400) | Shenzhen Saidi Light Therapy Technology Co., Ltd. | 2025-12-24 |
| Philips Lumea IPL (K253754) | Philips Consumer Lifestyle B.V. | 2025-12-23 |
| LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) (K253135) | Dongguan Yijiaming Technology Co., Ltd. | 2025-12-23 |
| KP Protective Face Mask (K243342) | Kp Trading Co., Ltd. | 2025-12-22 |
| STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K252743) | ETHICON, Inc. | 2025-12-22 |
| InnoClip Disposable Clip Applier (K253903) | Taiwan Surgical Corporation | 2025-12-22 |
| InnoClip Clip Applier (K253781) | Taiwan Surgical Corporation | 2025-12-22 |
| LED Light Therapy Device (Models: SG-FM, SG-FE) (K253086) | Sunglor Technology Co., Ltd. | 2025-12-19 |
| SCOUT MD Surgical Guidance System (K252892) | Merit Medical Systems, Inc. | 2025-12-19 |
| SANDRO Dual (K252877) | Wontech Co., Ltd. | 2025-12-19 |
| JOULE 1064nm System and Accessories (K251077) | Sciton, Inc | 2025-12-19 |
| CO2 Laser Therapy System (Model: LFS-D9U) (K250998) | Sanhe Lefis Electronics Co., Ltd. | 2025-12-19 |
| LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) (K253054) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | 2025-12-19 |
| MOVIVA® Hybrid Ablation Probe (K253915) | Erbe Elektromedizin GmbH | 2025-12-18 |
| Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) (K252983) | Shenzhen Goodwind Technology Development Co., Ltd. | 2025-12-17 |
| ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) (K252739) | Ethicon Endo-Surgery, LLC | 2025-12-17 |
| Versius Surgical System (Versius Plus) (K252111) | Cmr Surgical Limited | 2025-12-16 |
| VR® Personal Protective Level 3 Gown (VR Gowns) (K252940) | PolyConversions, Inc. | 2025-12-16 |
| TroClose 1200 (K253620) | Gordian Surgical, Ltd. | 2025-12-16 |
| Erchonia CLX (Model # CFL) (K252574) | Erchonia Corporation | 2025-12-15 |
| Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) (K252745) | Micro-Energy Medical Technology Co., Ltd. | 2025-12-12 |
| VizMark Preloaded Tissue Marker Device (VM-0001) (K251989) | Breast-Med, Inc. | 2025-12-12 |
| HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (K252941) | O&M Halyard, Inc. | 2025-12-11 |
| Lancing device (HH-XV-T) (K253706) | Tianjin Huahong Technology Co., Ltd. | 2025-12-09 |
| Focused Cryotherapy System (K250742) | Focused Cryo, Inc. | 2025-12-09 |
| LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) (K252994) | Guangdong Ace-Tec Co., Ltd. | 2025-12-08 |
| Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (K252142) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-05 |
| Hugo™ RAS System (K250725) | Covidien, LLC | 2025-12-03 |
| Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (K250564) | Yadu Medical (Henan) Co., Ltd. | 2025-12-03 |
| Led Light Phototherapy Bed (Pro 450/ GY-680A) (K252786) | Shenzhen Suyzeko Limited. | 2025-12-01 |
| Medical Diode Laser Systems (TR-B) (K252658) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 2025-11-28 |
| Dendrite Imaging System (K253303) | Dendrite Imaging, Inc. | 2025-11-28 |
| BELLUS-Q (K253344) | Speclipse, Inc. | 2025-11-25 |
| LeafPure-Echo (LM-LPNdA) (K253219) | Shenzhen Leaflife Technology Co., Ltd. | 2025-11-25 |
| IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) (K253304) | Dongguan Lide Electric Appliance Co., Ltd. | 2025-11-25 |
| Eva Scalp Cooling System (K252289) | Stemtech Medical Devices Private Limited | 2025-11-25 |
| 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) (K252771) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-24 |
| F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) (K252704) | F Care Systems USA, LLC | 2025-11-24 |
| Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) (K252787) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-24 |
| Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory (K250586) | Deroyal Industries, Inc. | 2025-11-21 |
| 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) (K253007) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-20 |
| CuRAS hybrid (K253123) | Classys, Inc. | 2025-11-20 |
| Disposable Polymer Ligation Clips (K250643) | Hangzhou Kangji Medical Instrument Co., Ltd. | 2025-11-20 |
| LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) (K253073) | Sunglor Technology Co., Ltd. | 2025-11-19 |
| IPL Hair Removal Device (SYL001AZ, SYL002AZ) (K253035) | Gu'An Yeolight Smart Electronics Co., Ltd. | 2025-11-19 |
| Microcurrent Facial Device (CEC101, EEI101) (K252642) | Shenzhen Dachi Communication Co., Ltd. | 2025-11-19 |
| TS-RF Generator (STS10) (K251566) | Starmed Co., Ltd. | 2025-11-17 |
| IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) (K252618) | Alovea Healthcare Co. , Ltd. | 2025-11-14 |
| LED Beauty Mask (RLBXX) (K252308) | Atop Lighting Co., Ltd. | 2025-11-13 |
| PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture (K243897) | ETHICON, Inc. | 2025-11-12 |
| XSTAT P15 (K253290) | Revmedx, Inc. | 2025-11-12 |
| Symani Surgical System (K252287) | Medical Microinstruments, Inc. | 2025-11-10 |
| Medical Diode Laser Systems (VeinCure) (K252564) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 2025-11-07 |
| CO2 Laser Therapy System (K106) (K252519) | Hebei Keylaser Sci-Tech Co.,Ltd | 2025-11-07 |
| Q-Switched Nd:Yag laser (K690) (K252515) | Hebei Keylaser Sci-Tech Co.,Ltd | 2025-11-06 |
| Venus Nova (FP-2001) (K252845) | Venus Concept, Inc. | 2025-11-06 |
| Tamburo Thulium Fiber Laser System (K251303) | Menovex Medical Technology (Shenzhen) Co., Ltd. | 2025-11-04 |
| PRIMED Surgical and Procedure Masks (K252964) | Primed Medical Products, Inc. | 2025-11-04 |
| Voyant® Open Fusion Device (EB240/Open Fusion) (K252740) | Applied Medical Resources Corp. | 2025-11-04 |
| Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) (K252412) | Applied Medical Resources Corporation | 2025-10-31 |
| Diode Laser Hair Removal Machine (GLD01) (K252427) | Sanhe Meditech Co., Ltd. | 2025-10-31 |
| Niti-S Esophageal Stent; Esophageal TTS Stent (K243619) | Taewoong Medical Co., Ltd. | 2025-10-30 |
| Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120) (K252529) | Boston Scientific Corporation | 2025-10-30 |
| HANAROSTENT Esophagus Upper (CCC) (K253327) | M.I.Tech Co., Ltd. | 2025-10-30 |
| ellacor System with Micro-Coring Technology (K252752) | Cytrellis Biosystems, Inc. | 2025-10-30 |
| SER Pen Carain MicroSystem (MP1209SP) (K253153) | Su-Ko Technologies, LLC | 2025-10-29 |
| PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch (K250275) | Baylis Medical Technologies, Inc. | 2025-10-28 |
| Patriot Duo (K251824) | Patriot Laser, LLC | 2025-10-27 |
| VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) (K252053) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | 2025-10-27 |
| Parietene™ Flat Sheet Mesh (K253125) | Medtronic - Sofradim Production | 2025-10-24 |
| MultiPulse TFL (K253100) | Asclepion Laser Technologies GmbH | 2025-10-23 |
| 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) (K252732) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-10-23 |
| Picosecond Laser Device (PF131-BI) (K252345) | Risu Medical Technology Co., Ltd. | 2025-10-23 |
| Pre-Sutured Tendon (K253145) | Rti Surgical, Inc. | 2025-10-22 |
| ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (K250126) | Livsmed, Inc. | 2025-10-21 |
| AVAVA™ Skin Treatment System (K252155) | AVAVA, Inc. | 2025-10-20 |
| Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) (K251414) | Feeltech Co., Ltd. | 2025-10-20 |
| Q-Switched Nd: YAG Laser machine (LFS-C13U) (K252319) | Sanhe Lefis Electronics Co., Ltd. | 2025-10-20 |
| 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) (K252264) | Shenzhen Zhenxing Ruitong Technology Co., Ltd. | 2025-10-17 |
| ProZip Knotless Implant (K253024) | Riverpoint Medical | 2025-10-16 |
| Light Therapy Mask (1019055) (K252093) | Merchsource, LLC | 2025-10-16 |
| CryoFreeze Wart and Skin Tag Remover (K253000) | Cryosurgery, Inc. | 2025-10-16 |
| TargetCool™ (RM-DT02W) (K253114) | Recensmedical, Inc. | 2025-10-16 |
| MateLaser Medical Diode Laser Systems (ML-DLS-30) (K250731) | Matelaser, Inc. | 2025-10-16 |