510(k) submissions
Filtered by Skin resurfacing · showing 1–50 of 151
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K261214 | PICO SHINING (PICO-K; PICOFY)Pigment treatment | Speclipse, Inc.Korea, Republic of | Picosecond | Class 2 | 2026-05-11 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II)Skin resurfacing | Nanjing Bestview Laser S&T Co., Ltd.China | CO2 | Class 2 | 2026-05-07 |
| K260257 | CO2 Laser SystemSurgical cutting | Sanhe Meditech Co., Ltd.China | CO2 | Class 2 | 2026-03-28 |
| K260632 | LASER THERMAL THERAPY KITSurgical cutting | Elesta S.P.AItaly | Nd:YAG | Class 2 | 2026-03-17 |
| K253920 | CO2 Laser Treatment Machine (CFR3M1)Surgical cutting | Haidari Beauty Technology (Beijing) Co., Ltd.China | CO2 | Class 2 | 2026-03-03 |
| K254271 | CAPRISurgical cutting | ORO Co., Ltd.Korea, Republic of | Diode | Class 2 | 2026-02-26 |
| K252561 | BTL-754FFSkin resurfacing | BTL Industries, Inc.United States | Er:YAG | Class 2 | 2026-02-18 |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Nd:YAG | Class 2 | 2026-01-24 |
| K252369 | Boston Pico755Pigment treatment | Boston Aesthetics, Inc.United States | Picosecond | Class 2 | 2026-01-21 |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U)Skin resurfacing | Sanhe Lefis Electronics Co., Ltd.China | CO2 | Class 2 | 2025-12-19 |
| K253344 | BELLUS-QSurgical cutting | Speclipse, Inc.Korea, Republic of | Q-Switched | Class 2 | 2025-11-25 |
| K252519 | CO2 Laser Therapy System (K106)Surgical cutting | Hebei Keylaser Sci-Tech Co.,LtdChina | CO2 | Class 2 | 2025-11-07 |
| K252515 | Q-Switched Nd:Yag laser (K690)Pigment treatment | Hebei Keylaser Sci-Tech Co.,LtdChina | Nd:YAG | Class 2 | 2025-11-06 |
| K253100 | MultiPulse TFLSurgical cutting | Asclepion Laser Technologies GmbHUnited States | Thulium fiber | Class 2 | 2025-10-23 |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Pigment treatment | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | Thulium fiber | Class 2 | 2025-10-23 |
| K251699 | The Botticelli (Model: Athena)Skin resurfacing | Bellamia Technologies, Inc.United States | Diode | Class 2 | 2025-10-08 |
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Surgical cutting | Jeisys Medical IncorporatedKorea, Republic of | Nd:YAG | Class 2 | 2025-10-03 |
| K251919 | Thulium Laser System (Deluxlase)Pigment treatment | Nanjing Bestview Laser S&T Co., Ltd.China | Thulium fiber | Class 2 | 2025-09-26 |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Alma Lasers, Inc.United States | CO2 | Class 2 | 2025-09-24 |
| K250165 | PastelleSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2025-07-03 |
| K243701 | AuroLase® SystemSurgical cutting | Nanospectra Biosciences, Inc.United States | Diode | Class 2 | 2025-07-02 |
| K250782 | Fractional CO2 Laser MachineSkin resurfacing | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | CO2 | Class 2 | 2025-06-12 |
| K250465 | CO2 Laser Machine (Lume)Surgical cutting | Nanjing Bestview Laser S&T Co., Ltd.China | CO2 | Class 2 | 2025-06-09 |
| K251230 | The Alma Hybrid Laser SystemSurgical cutting | Alma Lasers, Inc.United States | CO2 | Class 2 | 2025-05-21 |
| K250183 | CO2 Laser System (CO2 Laser SST-L23)Surgical cutting | Zhuozhou Summer Star Technologies Co., Ltd.China | CO2 | Class 2 | 2025-04-24 |
| K250809 | Stellar M22Hair removal | Lumenis Be, Ltd.Israel | Nd:YAG | Class 2 | 2025-04-16 |
| K243044 | Alma HarmonyHair removal | Alma Lasers, Inc.United States | Nd:YAG | Class 2 | 2025-04-11 |
| K250189 | AdvaTxVascular treatment | Advalight ApsDenmark | Nd:YAG | Class 2 | 2025-04-01 |
| K250113 | neoLaser Laser Surgery FibersSurgical cutting | G.N.S Neolaser , Ltd.Israel | Laser fiber / delivery | Class 2 | 2025-03-13 |
| 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 |
| K234004 | Medical diode laser systems (CHARISMA, REGAL)Skin resurfacing | Reveal Lasers , Ltd.United States | Diode | Class 2 | 2025-02-20 |
| K243780 | HELIOS 785 Pico (1754V2)Pigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2025-02-07 |
| 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 |
| 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 |
| 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 |
| 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 |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTSurgical cutting | Quanta System SpaItaly | CO2 | Class 2 | 2024-10-10 |
| K241672 | COPRO 3Surgical cutting | Amt Engineering Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2024-09-06 |
| K242142 | Fraxel® FTX Laser SystemSkin resurfacing | Solta MedicalUnited States | Other | Class 2 | 2024-08-21 |
| 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 |
| K240159 | InnoVoyce VYLOSurgical cutting | InnovoyceUnited States | Diode | Class 2 | 2024-05-29 |
| K233803 | UltraClear Laser System (N/A)Skin resurfacing | Acclaro CorporationUnited States | CO2 | Class 2 | 2024-05-08 |
| K232133 | Co2 Laser System, Models: PureLase And VanLaseSurgical cutting | Cpmt Laser (Canadian Pioneer Medical Technology Corporation)Canada | CO2 | Class 2 | 2024-04-16 |
| K240537 | SMARTXIDE PROSkin resurfacing | El.En S.P.A.Italy | CO2 | Class 2 | 2024-03-20 |
| K240497 | Smartxide Tetra ProSkin resurfacing | El.En S.P.A.Italy | CO2 | Class 2 | 2024-03-12 |
| K233024 | Alma HarmonySkin resurfacing | Alma Lasers, Inc.United States | Er:YAG | Class 2 | 2024-02-08 |
