510(k) submissions
All indexed GEX clearances · showing 101–150 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K243957 | PICOALEXPigment treatment | Wontech Co., Ltd.Korea, Republic of | Alexandrite | Class 2 | 2025-03-12 |
| K242207 | NOABLE LASERSurgical cutting | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Diode | Class 2 | 2025-03-07 |
| K242943 | Q Switched Nd:YAG Laser machine (QNHF-01)Pigment treatment | Beijing Nubway S&T Co., Ltd.China | Nd:YAG | Class 2 | 2025-03-03 |
| K234004 | Medical diode laser systems (CHARISMA, REGAL)Skin resurfacing | Reveal Lasers , Ltd.United States | Diode | Class 2 | 2025-02-20 |
| K243588 | Single Use CO2 Laser Fiber (HAF005001)Surgical cutting | Quanta System SpaItaly | CO2 | Class 2 | 2025-02-19 |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Surgical cutting | Wontech Co., Ltd.Korea, Republic of | Laser fiber / delivery | Class 2 | 2025-02-14 |
| K241527 | Pastelle ProPigment treatment | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2025-02-14 |
| K243780 | HELIOS 785 Pico (1754V2)Pigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2025-02-07 |
| K243465 | Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)Hair removal | Guangzhou Chuang Zao Mei Technology Co., Ltd.China | Diode | Class 2 | 2025-02-06 |
| K241270 | BTL-754Skin resurfacing | BTL Industries, Inc.United States | Er:YAG | Class 2 | 2025-01-30 |
| K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1)Surgical cutting | Beijing Sano Laser S&T Development Co.,LtdChina | CO2 | Class 2 | 2025-01-27 |
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Hair removal | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2024-12-30 |
| K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)Surgical cutting | Jiangxi Medex Technology Co., Ltd.China | Diode | Class 2 | 2024-12-26 |
| K243037 | Diode Laser System model Dawn-SSurgical cutting | Shanghai Wonderful Opto-Electrics Tech.Co.,LtdChina | Diode | Class 2 | 2024-12-26 |
| K243121 | SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;Surgical cutting | Jiangxi Medex Technology Co., Ltd.China | Diode | Class 2 | 2024-12-22 |
| K243147 | LGO-Surgical Laser FibersSurgical cutting | Light Guide Optics International , Ltd.Latvia | Laser fiber / delivery | Class 2 | 2024-12-21 |
| K242534 | HandPICO Fractional Laser Handpiece TipPigment treatment | Vydence MedicalBrazil | Picosecond | Class 2 | 2024-12-20 |
| K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)Surgical cutting | Beijing Adss Development Co., Ltd.China | CO2 | Class 2 | 2024-12-20 |
| K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE)Surgical cutting | Allengers Global Healthcare Private LimitedIndia | Thulium fiber | Class 2 | 2024-12-17 |
| K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q)Surgical cutting | Rhein Laser Technologies Co., Ltd.China | Thulium fiber | Class 2 | 2024-11-19 |
| K241498 | Diode laser Treatment System (K18)Hair removal | Hebei Keylaser Sci-Tech Co.,LtdChina | Diode | Class 2 | 2024-11-18 |
| K241930 | VeincareVascular treatment | Wontech Co., Ltd.Korea, Republic of | Diode | Class 2 | 2024-11-14 |
| K241646 | ORTIV (ORTIV-BL, ORTIV-WH)Surgical cutting | Mvitro Co., Ltd.Korea, Republic of | Er:YAG | Class 2 | 2024-11-01 |
| K240543 | Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)Surgical cutting | Medency S.R.L.Italy | Diode | Class 2 | 2024-10-24 |
| K242183 | Fractional CO2 Laser Therapy System (EXFU CO2)Skin resurfacing | Weifang Mingliang Electronics Co., Ltd.China | CO2 | Class 2 | 2024-10-23 |
| K242132 | FREDDOSurgical cutting | Fabinject Lndustria E Comercio Lmportacao E Exportacao LtdaBrazil | Other | Class 2 | 2024-10-18 |
| K242035 | Accure Laser SystemAcne treatment | Accure Acne, Inc.United States | Other | Class 2 | 2024-10-11 |
| K241951 | Lasya-TrinityHair removal | BLUECORE COMPANY Co., Ltd.Korea, Republic of | Diode | Class 2 | 2024-10-10 |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTSurgical cutting | Quanta System SpaItaly | CO2 | Class 2 | 2024-10-10 |
| K231948 | MEDIYAGPigment treatment | Medicreations, LLCUnited States | Nd:YAG | Class 2 | 2024-10-09 |
| K242206 | ACTIVOSurgical cutting | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2024-09-27 |
| K241860 | Diode Laser Hair Removal SystemHair removal | Beijing Winkonlaser Technology LimitedChina | Diode | Class 2 | 2024-09-25 |
| K240604 | MTONE EVO (MTONE EVO)Vascular treatment | M&T S.R.L.Italy | Diode | Class 2 | 2024-09-20 |
| K241771 | Liftendo; Liftendo 2.0Surgical cutting | Medical San Indústria DE Equipamentos Médicos Ltda.Brazil | Diode | Class 2 | 2024-09-16 |
| K242349 | FoLixHair removal | Lumenis Be, Ltd.Israel | Other | Class 2 | 2024-09-09 |
| K241672 | COPRO 3Surgical cutting | Amt Engineering Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2024-09-06 |
| K242251 | Litho 60; Litho 100; Litho 150Surgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2024-09-03 |
| K242202 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2024-08-23 |
| K242191 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Surgical cutting | Olympus Surgical Technologies AmericaUnited States | Thulium fiber | Class 2 | 2024-08-23 |
| K242142 | Fraxel® FTX Laser SystemSkin resurfacing | Solta MedicalUnited States | Other | Class 2 | 2024-08-21 |
| K241699 | SUPER VELOCESurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2024-08-13 |
| K241547 | Diode Laser Therapy Device (DF-DIODE LASER-S1)Hair removal | Weifang Dragonfly Electronics Technology Co., Ltd.China | Diode | Class 2 | 2024-08-13 |
| K241656 | Eneka SelectifHair removal | TermosaludSpain | Alexandrite | Class 2 | 2024-08-12 |
| K231950 | MEDIDIODEHair removal | Medicreations, LLCUnited States | Diode | Class 2 | 2024-08-09 |
| K241642 | Diode Laser Hair Removal System (MBT-Diode Laser)Hair removal | Beijing Mega Beauty Technology Co., Ltd.China | Diode | Class 2 | 2024-08-02 |
| K241293 | LED Light Therapy Device, ELIXIR MD™Acne treatment | Yassen Wellness, LLCUnited States | LED | Class 2 | 2024-07-08 |
| K241600 | DermablateSkin resurfacing | Asclepion Laser Technologies GmbHUnited States | CO2 | Class 2 | 2024-07-03 |
| K241406 | LavieenPigment treatment | Wontech Co., Ltd.Korea, Republic of | Thulium fiber | Class 2 | 2024-06-28 |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Pigment treatment | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2024-06-24 |
| K241459 | MOTUS PRO FamilyHair removal | El.En S.P.A.Italy | Diode | Class 2 | 2024-06-21 |
