510(k) submissions
All indexed GEX clearances · showing 151–200 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K240611 | IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Hair removal | Ivylaser (Beijing) Technology Co.,LtdChina | Diode | Class 2 | 2024-06-20 |
| K240747 | Medical Diode Laser (M2-GK)Surgical cutting | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2024-06-17 |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Hair removal | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2024-06-14 |
| K241358 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170EAcne treatment | Sun Pharmaceutical Industries, Inc.United States | LED | Class 2 | 2024-06-13 |
| K233007 | Picosecond Nd:YAG Laser System; PICO LEGENDPigment treatment | Ami, Inc.Korea, Republic of | Nd:YAG | Class 2 | 2024-06-12 |
| K240644 | Medical Diode Laser (S1Pro)Surgical cutting | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2024-06-10 |
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Acne treatment | Aesthetic Technology, Ltd.United Kingdom | LED | Class 2 | 2024-06-04 |
| K240159 | InnoVoyce VYLOSurgical cutting | InnovoyceUnited States | Diode | Class 2 | 2024-05-29 |
| K240874 | Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)Hair removal | Theralaser Medtech (China) Co., Ltd.China | Diode | Class 2 | 2024-05-28 |
| K233344 | Regenalase Laser SystemSurgical cutting | Ipg Medical CorporationUnited States | Diode | Class 2 | 2024-05-28 |
| K240520 | Diode Laser Hair Removal System (SH-VD910)Hair removal | Beijing Sea Heart International Science and Technologyco.LtdChina | Diode | Class 2 | 2024-05-20 |
| K240474 | Multi-function Platform Systems (BL-M10)Hair removal | Shanghai Bele Medical Technology Co.,LtdChina | Nd:YAG | Class 2 | 2024-05-20 |
| K240752 | DEKA TOROPigment treatment | El.En S.P.A.Italy | Q-Switched | Class 2 | 2024-05-16 |
| K240386 | Picosecond Nd:YAG Laser Systems (BL-C10)Pigment treatment | Shanghai Bele Medical Technology Co.,LtdChina | Nd:YAG | Class 2 | 2024-05-16 |
| K233803 | UltraClear Laser System (N/A)Skin resurfacing | Acclaro CorporationUnited States | CO2 | Class 2 | 2024-05-08 |
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDDSurgical cutting | Innovaquartz, LLCUnited States | Laser fiber / delivery | Class 2 | 2024-05-03 |
| K232858 | ORskin BlueSurgical cutting | Megabay S.A.Argentina | Other | Class 2 | 2024-05-01 |
| K240118 | Picosecond Nd:YAG Laser SystemPigment treatment | Smedtrum Medical Technology Co., Ltd.Taiwan | Nd:YAG | Class 2 | 2024-04-30 |
| K240816 | MeDioStarHair removal | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2024-04-23 |
| K232133 | Co2 Laser System, Models: PureLase And VanLaseSurgical cutting | Cpmt Laser (Canadian Pioneer Medical Technology Corporation)Canada | CO2 | Class 2 | 2024-04-16 |
| K233757 | TitanPico Laser Workstation (PICO-450)Pigment treatment | Rhein Laser Technologies Co., Ltd.China | Picosecond | Class 2 | 2024-04-11 |
| K234057 | NIRVANAHair removal | El.En S.P.A.Italy | Diode | Class 2 | 2024-04-10 |
| K234085 | LUNE™ PureHygieneDental | Enamel PureUnited States | CO2 | Class 2 | 2024-03-25 |
| K240179 | Medical Diode Laser (Model: L2)Surgical cutting | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2024-03-21 |
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesSurgical cutting | Ipg Medical CorporationUnited States | Thulium fiber | Class 2 | 2024-03-21 |
| K240537 | SMARTXIDE PROSkin resurfacing | El.En S.P.A.Italy | CO2 | Class 2 | 2024-03-20 |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser)Pigment treatment | Wontech Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2024-03-15 |
| K240497 | Smartxide Tetra ProSkin resurfacing | El.En S.P.A.Italy | CO2 | Class 2 | 2024-03-12 |
| K240132 | EmoLED (v. 2-USA)Acne treatment | Emoled, SrlItaly | LED | Class 2 | 2024-03-12 |
| K240396 | Elite iQ PRO (M122K1)Hair removal | Cynosure, LLCUnited States | Alexandrite | Class 2 | 2024-03-08 |
| K231876 | MultiPulse HoPLUSSurgical cutting | Asclepion Laser Technologies GmbHUnited States | Holmium (Ho:YAG) | Class 2 | 2024-02-22 |
| K231896 | Diode Laser Therapy SystemHair removal | Beijing Adss Development Co., Ltd.China | Diode | Class 2 | 2024-02-20 |
| K231514 | AzureSurgical cutting | Daeshin Enterprise Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2024-02-14 |
| K233024 | Alma HarmonySkin resurfacing | Alma Lasers, Inc.United States | Er:YAG | Class 2 | 2024-02-08 |
| K233416 | Cryojet Plus (SHE-ACP001-1)Skin tightening | Beijing Sano Laser S&T Development Co.,LtdChina | Other | Class 2 | 2024-02-06 |
| K233756 | Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)Hair removal | Rhein Laser Technologies Co., Ltd.China | Diode | Class 2 | 2024-02-02 |
| K233143 | PiXel8-RevealSkin resurfacing | Rohrer AestheticsUnited States | Er:YAG | Class 2 | 2024-02-02 |
| K233804 | Resonic Rapid Acoustic Pulse DeviceOther | Zeltiq Aesthetics, Inc.United States | Q-Switched | Class 2 | 2024-02-01 |
| K231910 | DermRays ReviveHair removal | Wuhan Lotuxs Technology Co., Ltd.China | Diode | Class 2 | 2024-01-30 |
| K233224 | Epilaser ProHair removal | Epilady 2000, LLCIsrael | Diode | Class 2 | 2024-01-27 |
| K233077 | FlashHeal 2 (FlashHeal 2.0)Acne treatment | Inwound ApsDenmark | LED | Class 2 | 2024-01-18 |
| K232106 | Air Gap FiberSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Laser fiber / delivery | Class 2 | 2024-01-08 |
| K221766 | SolonHair removal | Lmg Lasers Comercio, Importacao E Exportacao LtdaBrazil | Diode | Class 2 | 2024-01-05 |
| K233304 | Omnimax S3, Omnimax S4Hair removal | Sharplight Technologies, Ltd.Israel | IPL | Class 2 | 2023-12-22 |
| K233018 | PICOSECOND Nd:YAG Laser SystemPigment treatment | Ids, LimitedKorea, Republic of | Picosecond | Class 2 | 2023-12-21 |
| K233237 | xeo+ FamilyHair removal | Cutera, Inc.United States | IPL | Class 2 | 2023-12-15 |
| K231061 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2023-12-08 |
| K232769 | BeaMed Laser Surgery FibersSurgical cutting | Bt Beamedical Tachnoogies Ltd. (Beamed)Israel | Laser fiber / delivery | Class 2 | 2023-12-06 |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Lumenis Be, Ltd.Israel | CO2 | Class 2 | 2023-12-01 |
| K232716 | Q-Switched Nd:Yag laserPigment treatment | Hebei Zhemai Technology Co., Ltd.China | Nd:YAG | Class 2 | 2023-11-30 |
