510(k) submissions
Filtered by Acne treatment · showing 1–50 of 84
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K253765 | VANISH PROPigment treatment | Ddc Technologies, Inc.United States | Nd:YAG | Class 2 | 2026-04-22 |
| K252971 | Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)Surgical cutting | C.R. Bard, Inc.United States | Thulium fiber | Class 2 | 2026-03-17 |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Nd:YAG | Class 2 | 2026-03-06 |
| K254271 | CAPRISurgical cutting | ORO Co., Ltd.Korea, Republic of | Diode | Class 2 | 2026-02-26 |
| K252753 | Vydence Family of LasersHair removal | Vydence Medical Industria E Commercio LtdaBrazil | Nd:YAG | Class 2 | 2026-01-24 |
| K252369 | Boston Pico755Pigment treatment | Boston Aesthetics, Inc.United States | Picosecond | Class 2 | 2026-01-21 |
| K253342 | PICO-KPigment treatment | Speclipse, Inc.Korea, Republic of | Picosecond | Class 2 | 2025-12-24 |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Thulium fiber | Class 2 | 2025-11-24 |
| K252515 | Q-Switched Nd:Yag laser (K690)Pigment treatment | Hebei Keylaser Sci-Tech Co.,LtdChina | Nd:YAG | Class 2 | 2025-11-06 |
| K251824 | Patriot DuoSurgical cutting | Patriot Laser, LLCUnited States | Laser fiber / delivery | Class 2 | 2025-10-27 |
| K251699 | The Botticelli (Model: Athena)Skin resurfacing | Bellamia Technologies, Inc.United States | Diode | Class 2 | 2025-10-08 |
| K251727 | GLAM LED Facial Mask (TB-2386F)Acne treatment | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-08-29 |
| K251149 | AviClear Laser SystemAcne treatment | Cutera, Inc.United States | Other | Class 2 | 2025-07-11 |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser FibersSurgical cutting | Boston Scientific CorporationUnited States | Laser fiber / delivery | Class 2 | 2025-07-09 |
| K250722 | Nd: YAG Laser Therapy System (QN-1)Pigment treatment | Hebei JT Medical Co., Ltd.China | Nd:YAG | Class 2 | 2025-06-06 |
| K250195 | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)Vascular treatment | Matelaser, Inc.United States | Other | Class 2 | 2025-05-30 |
| K250189 | AdvaTxVascular treatment | Advalight ApsDenmark | Nd:YAG | Class 2 | 2025-04-01 |
| K243993 | Photon Therapy Apparatus (BL-10)Pigment treatment | Xemis Medical Technology (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-03-13 |
| K242207 | NOABLE LASERSurgical cutting | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Diode | Class 2 | 2025-03-07 |
| K241270 | BTL-754Skin resurfacing | BTL Industries, Inc.United States | Er:YAG | Class 2 | 2025-01-30 |
| K242534 | HandPICO Fractional Laser Handpiece TipPigment treatment | Vydence MedicalBrazil | Picosecond | 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 |
| 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 |
| K242035 | Accure Laser SystemAcne treatment | Accure Acne, Inc.United States | Other | Class 2 | 2024-10-11 |
| K231948 | MEDIYAGPigment treatment | Medicreations, LLCUnited States | Nd:YAG | Class 2 | 2024-10-09 |
| 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 |
| K241699 | SUPER VELOCESurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2024-08-13 |
| K241293 | LED Light Therapy Device, ELIXIR MD™Acne treatment | Yassen Wellness, LLCUnited States | LED | Class 2 | 2024-07-08 |
| K241358 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170EAcne treatment | Sun Pharmaceutical Industries, Inc.United States | LED | Class 2 | 2024-06-13 |
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Acne treatment | Aesthetic Technology, Ltd.United Kingdom | LED | Class 2 | 2024-06-04 |
| K240474 | Multi-function Platform Systems (BL-M10)Hair removal | Shanghai Bele Medical Technology Co.,LtdChina | Nd:YAG | Class 2 | 2024-05-20 |
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesSurgical cutting | Ipg Medical CorporationUnited States | Thulium fiber | Class 2 | 2024-03-21 |
| K240132 | EmoLED (v. 2-USA)Acne treatment | Emoled, SrlItaly | LED | Class 2 | 2024-03-12 |
| K233077 | FlashHeal 2 (FlashHeal 2.0)Acne treatment | Inwound ApsDenmark | LED | Class 2 | 2024-01-18 |
| K233304 | Omnimax S3, Omnimax S4Hair removal | Sharplight Technologies, Ltd.Israel | IPL | Class 2 | 2023-12-22 |
| K231061 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2023-12-08 |
| K232716 | Q-Switched Nd:Yag laserPigment treatment | Hebei Zhemai Technology Co., Ltd.China | Nd:YAG | Class 2 | 2023-11-30 |
| K231894 | LED Spectrum therapy instrumentAcne treatment | Shenzhenshi Sincoheren S&T Development Co., Ltd.China | LED | Class 2 | 2023-09-20 |
| K231718 | Holmium Medical LaserSurgical cutting | Allengers Global Healthcare Private LimitedIndia | Holmium (Ho:YAG) | Class 2 | 2023-08-18 |
| K230342 | Phototherapy System (OL-PDT950)Acne treatment | Shanghai Omni Laser Skinology Co., Ltd.China | LED | Class 2 | 2023-08-16 |
| K230660 | AviClear Laser SystemAcne treatment | Cutera, Inc.United States | Diode | Class 2 | 2023-06-06 |
| K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmSkin resurfacing | Gme German Medical Engineering GmbHUnited States | Laser fiber / delivery | Class 2 | 2023-03-10 |
| K222751 | LED Light Therapy Device, KN-7000LAcne treatment | Xuzhou Kernel Medical Equipment Co., Ltd.China | LED | Class 2 | 2023-02-01 |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesSurgical cutting | Gyrus Acmi, Inc.United States | Thulium fiber | Class 2 | 2023-01-27 |
| K222109 | Accure LaserAcne treatment | Accure Acne, Inc.United States | Other | Class 2 | 2022-11-17 |
| K202953 | Aurolase Therapy, Laser Delivery Device (LDD)Acne treatment | Nanospectra Biosciences, Inc.United States | Diode | Class 2 | 2022-10-03 |
| K213252 | Dornier ThulioSurgical cutting | Dornier Medtech America, Inc.United States | Thulium fiber | Class 2 | 2022-07-27 |
| K221083 | Smartlux MiniAcne treatment | Medmix Co., Ltd.Korea, Republic of | Other | Class 2 | 2022-07-12 |
| K214049 | Leaseir MHR XcellHair removal | Leaseir Technologies, SluSpain | Diode | Class 2 | 2022-06-02 |
| K220041 | HandPICOAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2022-05-05 |