510(k) submissions
Filtered by Pigment treatment · showing 1–50 of 195
| 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 |
| K260256 | Q-Switched Nd: YAG Laser SystemsPigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Q-Switched | Class 2 | 2026-05-04 |
| K261094 | YellowStarVascular treatment | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2026-04-29 |
| K253765 | VANISH PROPigment treatment | Ddc Technologies, Inc.United States | Nd:YAG | Class 2 | 2026-04-22 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q)Pigment treatment | Nanjing Bestview Laser S&T Co., Ltd.China | Q-Switched | Class 2 | 2026-04-20 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298)Pigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Nd:YAG | Class 2 | 2026-04-09 |
| K260375 | Nd: YAG Laser Therapy SystemsPigment treatment | Sanhe Meditech Co., Ltd.China | Nd:YAG | Class 2 | 2026-03-31 |
| K253829 | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Pigment treatment | Beijing HuaCheng Taike Technology Co., Ltd.China | Picosecond | Class 2 | 2026-02-27 |
| K252561 | BTL-754FFSkin resurfacing | BTL Industries, Inc.United States | Er:YAG | Class 2 | 2026-02-18 |
| K251981 | Boston PICO (Boston PICO)Pigment treatment | Boston Aesthetics, Inc.United States | Picosecond | Class 2 | 2026-01-30 |
| 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 |
| K253344 | BELLUS-QSurgical cutting | Speclipse, Inc.Korea, Republic of | Q-Switched | Class 2 | 2025-11-25 |
| K253219 | LeafPure-Echo (LM-LPNdA)Pigment treatment | Shenzhen Leaflife Technology Co., Ltd.China | Nd:YAG | Class 2 | 2025-11-25 |
| K253123 | CuRAS hybridSurgical cutting | Classys, Inc.Korea, Republic of | Nd:YAG | Class 2 | 2025-11-20 |
| K252515 | Q-Switched Nd:Yag laser (K690)Pigment treatment | Hebei Keylaser Sci-Tech Co.,LtdChina | Nd:YAG | Class 2 | 2025-11-06 |
| 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 |
| K252345 | Picosecond Laser Device (PF131-BI)Pigment treatment | Risu Medical Technology Co., Ltd.China | Picosecond | Class 2 | 2025-10-23 |
| K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U)Pigment treatment | Sanhe Lefis Electronics Co., Ltd.China | Nd:YAG | Class 2 | 2025-10-20 |
| K251699 | The Botticelli (Model: Athena)Skin resurfacing | Bellamia Technologies, Inc.United States | Diode | Class 2 | 2025-10-08 |
| K252447 | Picosecond laser device (BMPS4)Pigment treatment | Hebei Newangie Technology Co., Ltd.China | Picosecond | Class 2 | 2025-10-01 |
| K251919 | Thulium Laser System (Deluxlase)Pigment treatment | Nanjing Bestview Laser S&T Co., Ltd.China | Thulium fiber | Class 2 | 2025-09-26 |
| K251432 | OloVascular treatment | El.En S.P.A.Italy | Nd:YAG | Class 2 | 2025-08-06 |
| K250165 | PastelleSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2025-07-03 |
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1)Pigment treatment | Beijing Sano Laser S&T Development Co.,LtdChina | Nd:YAG | Class 2 | 2025-06-12 |
| K250722 | Nd: YAG Laser Therapy System (QN-1)Pigment treatment | Hebei JT Medical Co., Ltd.China | Nd:YAG | Class 2 | 2025-06-06 |
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico DermPigment treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2025-06-06 |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6)Pigment treatment | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | Picosecond | Class 2 | 2025-05-14 |
| 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 |
| K243993 | Photon Therapy Apparatus (BL-10)Pigment treatment | Xemis Medical Technology (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-03-13 |
| K243957 | PICOALEXPigment treatment | Wontech Co., Ltd.Korea, Republic of | Alexandrite | Class 2 | 2025-03-12 |
| 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 |
| 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 |
| K241270 | BTL-754Skin resurfacing | BTL Industries, Inc.United States | Er:YAG | Class 2 | 2025-01-30 |
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Hair removal | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2024-12-30 |
| K242534 | HandPICO Fractional Laser Handpiece TipPigment treatment | Vydence MedicalBrazil | Picosecond | Class 2 | 2024-12-20 |
| 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 |
| K240604 | MTONE EVO (MTONE EVO)Vascular treatment | M&T S.R.L.Italy | Diode | Class 2 | 2024-09-20 |
| K241699 | SUPER VELOCESurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2024-08-13 |
| K241656 | Eneka SelectifHair removal | TermosaludSpain | Alexandrite | Class 2 | 2024-08-12 |
| K241293 | LED Light Therapy Device, ELIXIR MD™Acne treatment | Yassen Wellness, LLCUnited States | LED | Class 2 | 2024-07-08 |
| 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 |
