510(k) submissions
Filtered by Er:YAG · showing 1–28 of 28
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K252561 | BTL-754FFSkin resurfacing | BTL Industries, Inc.United States | Er:YAG | Class 2 | 2026-02-18 |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Er:YAG | Class 2 | 2025-11-24 |
| K250776 | Lithoblast Single Use Holmium Laser FibersSurgical cutting | Dawell Medical, LLCUnited States | Er:YAG | Class 2 | 2025-10-14 |
| K241270 | BTL-754Skin resurfacing | BTL Industries, Inc.United States | Er:YAG | Class 2 | 2025-01-30 |
| K241646 | ORTIV (ORTIV-BL, ORTIV-WH)Surgical cutting | Mvitro Co., Ltd.Korea, Republic of | Er:YAG | Class 2 | 2024-11-01 |
| K242202 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2024-08-23 |
| K233024 | Alma HarmonySkin resurfacing | Alma Lasers, Inc.United States | Er:YAG | Class 2 | 2024-02-08 |
| K233143 | PiXel8-RevealSkin resurfacing | Rohrer AestheticsUnited States | Er:YAG | Class 2 | 2024-02-02 |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser SystemSkin resurfacing | Solta MedicalUnited States | Er:YAG | Class 2 | 2022-12-29 |
| K213267 | Dynamis Pro FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2022-09-08 |
| K212492 | Frax 1940 for Nordlys and Frax ProSkin resurfacing | Candela CorporationUnited States | Er:YAG | Class 2 | 2021-12-20 |
| K202258 | ERISE Laser handpieceSkin resurfacing | El.En Electronic Engineering SpaItaly | Er:YAG | Class 2 | 2021-04-26 |
| K202985 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2021-03-19 |
| K193656 | SkyPulseSurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2020-03-27 |
| K192951 | Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunHair removal | Ellipse A/SDenmark | Er:YAG | Class 2 | 2020-03-26 |
| K193661 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2020-03-25 |
| K190319 | Waterlase Laser System FamilyDental | Biolase, Inc.United States | Er:YAG | Class 2 | 2019-10-10 |
| K191554 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2019-08-30 |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser SystemSurgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Er:YAG | Class 2 | 2018-12-27 |
| K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroSurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2018-10-31 |
| K173285 | JOULE SYSTEMSkin resurfacing | Sciton, IncUnited States | Er:YAG | Class 2 | 2018-01-29 |
| K173002 | 2940 nm Er:Yag Laser HandpieceSkin resurfacing | Quanta System SpaItaly | Er:YAG | Class 2 | 2017-12-13 |
| K170073 | LightMed Dental Laser SystemSurgical cutting | Lightmed Dentaltechnology Corp.Taiwan | Er:YAG | Class 2 | 2017-07-25 |
| K163196 | ACTION II Laser SystemSurgical cutting | Lutronic CorporationKorea, Republic of | Er:YAG | Class 2 | 2017-05-24 |
| K152737 | Lite TouchSurgical cutting | Focus Medical, LLCUnited States | Er:YAG | Class 2 | 2016-06-29 |
| K150664 | NeoLasSurgical cutting | Sheaumann Laser, Inc.United States | Er:YAG | Class 2 | 2015-12-22 |
| K152153 | MicroSpot HandpieceSkin resurfacing | Asclepion Laser Technologies GmbHUnited States | Er:YAG | Class 2 | 2015-12-11 |
| K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroSurgical cutting | Fotona D.D.Slovenia | Er:YAG | Class 2 | 2015-04-09 |