510(k) submissions
Filtered by Pigment treatment · showing 51–100 of 195
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Hair removal | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2024-06-14 |
| K233007 | Picosecond Nd:YAG Laser System; PICO LEGENDPigment treatment | Ami, Inc.Korea, Republic of | Nd:YAG | Class 2 | 2024-06-12 |
| 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 |
| 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 |
| 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 |
| K233757 | TitanPico Laser Workstation (PICO-450)Pigment treatment | Rhein Laser Technologies Co., Ltd.China | Picosecond | Class 2 | 2024-04-11 |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser)Pigment treatment | Wontech Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2024-03-15 |
| K240396 | Elite iQ PRO (M122K1)Hair removal | Cynosure, LLCUnited States | Alexandrite | Class 2 | 2024-03-08 |
| 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 |
| K233018 | PICOSECOND Nd:YAG Laser SystemPigment treatment | Ids, LimitedKorea, Republic of | Picosecond | Class 2 | 2023-12-21 |
| K232716 | Q-Switched Nd:Yag laserPigment treatment | Hebei Zhemai Technology Co., Ltd.China | Nd:YAG | Class 2 | 2023-11-30 |
| K232532 | Nd:Yag Laser Therapy SystemsSurgical cutting | Beijing Unt Technology Co., Ltd.China | Nd:YAG | Class 2 | 2023-11-02 |
| K223727 | LavieenPigment treatment | Wontech Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2023-08-25 |
| K230342 | Phototherapy System (OL-PDT950)Acne treatment | Shanghai Omni Laser Skinology Co., Ltd.China | LED | Class 2 | 2023-08-16 |
| K231054 | V-LaserVascular treatment | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2023-08-14 |
| K230077 | LaserMESkin resurfacing | Neauvia North AmericaUnited States | CO2 | Class 2 | 2023-07-17 |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Vascular treatment | Candela CorporationUnited States | Other | Class 2 | 2023-06-01 |
| K230373 | HELIOS 785 PicoSurgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2023-05-22 |
| K230340 | Lucas PlusSurgical cutting | Amt Engineering Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2023-05-04 |
| 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 |
| K230308 | Alma HarmonyHair removal | Alma Lasers, Inc.United States | IPL | Class 2 | 2023-03-01 |
| K222751 | LED Light Therapy Device, KN-7000LAcne treatment | Xuzhou Kernel Medical Equipment Co., Ltd.China | LED | Class 2 | 2023-02-01 |
| K223588 | PALLAS PremiumPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Other | Class 2 | 2023-01-26 |
| K222673 | Alexandrite and Nd:YAG Laser models CANLASE and TORLASEHair removal | Canadian Pioneer Medical Technology Corporation (Cpmt Laser)Canada | Alexandrite | Class 2 | 2022-11-17 |
| K220853 | PicoWay Laser SystemPigment treatment | Candela CorporationUnited States | Picosecond | Class 2 | 2022-10-13 |
| K222629 | Resonic Rapid Acoustic Pulse DevicePigment treatment | Zeltiq Aesthetics, Inc.United States | Q-Switched | Class 2 | 2022-09-25 |
| K222555 | reepot Nd; YAG laser systemSurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-09-23 |
| K220268 | Picosecond Laser System (Model PS10-A and PS10-B)Pigment treatment | Beijing Adss Development Co., Ltd.China | Picosecond | Class 2 | 2022-08-23 |
| K221789 | IRIS Pi Q switched Nd YAG laserSurgical cutting | Bio-Med USA, Inc.United States | Nd:YAG | Class 2 | 2022-08-09 |
| K213726 | PL-1 Skin Treatment SystemPigment treatment | AVAVA, Inc.United States | Nd:YAG | Class 2 | 2022-06-28 |
| K212663 | HELIOS IV 785Surgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-06-09 |
| K220041 | HandPICOAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2022-05-05 |
| K213889 | PicoStarPigment treatment | Asclepion Laser Technologies GmbHUnited States | Picosecond | Class 2 | 2022-04-22 |
| K213569 | HOLLYWOOD SPECTRA Laser SystemPigment treatment | Lutronic CorporationKorea, Republic of | Q-Switched | Class 2 | 2022-02-04 |
| K211228 | RossoPigment treatment | Quanta System SpaItaly | Ruby | Class 2 | 2022-02-02 |
| K212127 | PicocaremajestyPigment treatment | Wontech Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2022-01-07 |
| K212492 | Frax 1940 for Nordlys and Frax ProSkin resurfacing | Candela CorporationUnited States | Er:YAG | Class 2 | 2021-12-20 |
| K202848 | S2 Pigment Removal SystemPigment treatment | Lightsense Technologies, Ltd.United Kingdom | Nd:YAG | Class 2 | 2021-12-14 |
| K212573 | PicoLO PremiumPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2021-12-08 |
| K202288 | FinebeamPigment treatment | SNJ Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2021-11-19 |
| K212607 | DarwinHair removal | Luvo Medical Technologies, Inc.Canada | Diode | Class 2 | 2021-11-15 |
| K212502 | Resonic Rapid Acoustic Pulse DevicePigment treatment | Soliton, Inc.United States | Nd:YAG | Class 2 | 2021-11-05 |
| K202998 | Vydence Zye and Vydence OneAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2021-10-26 |
| K201773 | PICOHIPigment treatment | Hironic Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2021-10-19 |
| K212082 | PicorePigment treatment | Bio-Med USA, Inc.United States | Q-Switched | Class 2 | 2021-10-06 |
| K211637 | AROMA GRANDHair removal | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Diode | Class 2 | 2021-09-03 |