510(k) submissions
Filtered by Skin tightening · showing 1–25 of 25
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K251727 | GLAM LED Facial Mask (TB-2386F)Acne treatment | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-08-29 |
| K243993 | Photon Therapy Apparatus (BL-10)Pigment treatment | Xemis Medical Technology (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-03-13 |
| K241293 | LED Light Therapy Device, ELIXIR MD™Acne treatment | Yassen Wellness, LLCUnited States | LED | Class 2 | 2024-07-08 |
| K233416 | Cryojet Plus (SHE-ACP001-1)Skin tightening | Beijing Sano Laser S&T Development Co.,LtdChina | Other | Class 2 | 2024-02-06 |
| 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 |
| K233077 | FlashHeal 2 (FlashHeal 2.0)Acne treatment | Inwound ApsDenmark | LED | Class 2 | 2024-01-18 |
| K221766 | SolonHair removal | Lmg Lasers Comercio, Importacao E Exportacao LtdaBrazil | Diode | Class 2 | 2024-01-05 |
| K231061 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2023-12-08 |
| K231894 | LED Spectrum therapy instrumentAcne treatment | Shenzhenshi Sincoheren S&T Development Co., Ltd.China | LED | Class 2 | 2023-09-20 |
| K221427 | V-LaserSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-08-24 |
| K221083 | Smartlux MiniAcne treatment | Medmix Co., Ltd.Korea, Republic of | Other | Class 2 | 2022-07-12 |
| K220020 | Cryo 7Skin tightening | Zimmer Medizinsysteme GmbHUnited States | Other | Class 2 | 2022-02-04 |
| K202175 | OxyLight 2.0Acne treatment | Raja Trading Company, Inc.United States | LED | Class 2 | 2021-12-02 |
| K212607 | DarwinHair removal | Luvo Medical Technologies, Inc.Canada | Diode | Class 2 | 2021-11-15 |
| K212270 | DEKA LipoAISurgical cutting | El.En Electronic Engineering SpaItaly | Nd:YAG | Class 2 | 2021-10-21 |
| K202041 | Opera EvoSurgical cutting | Quanta System SpaItaly | Diode | Class 2 | 2020-10-15 |
| K200104 | OxylightAcne treatment | Raja Trading Company, Inc.United States | LED | Class 2 | 2020-06-04 |
| K192755 | Soli-Lite LG4 GalileoAcne treatment | Silhouet-Tone CorporationCanada | LED | Class 2 | 2019-12-20 |
| K183156 | V-LaserSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2019-04-24 |
| K183452 | Vbeam Prima Laser SystemVascular treatment | Candela CorporationUnited States | Nd:YAG | Class 2 | 2019-02-01 |
| K170850 | Alma QVascular treatment | Alma Lasers, Inc.Israel | Q-Switched | Class 2 | 2017-06-15 |
| K162556 | LIGHTFUSION LED SYSTEMSkin tightening | Vitage Led, Ltd.United Kingdom | Other | Class 2 | 2017-03-24 |
| K162851 | eLyx-PROAcne treatment | Intelligent Sensory Concept SASwitzerland | Other | Class 2 | 2017-01-24 |
| K160227 | ACCENTO / HWA Dual/Single laserHair removal | Bison Medical Co, Ltd.Korea, Republic of | Alexandrite | Class 2 | 2016-04-22 |