FDA Product Code
FDA Product Code GEX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 2,887 records · page 1 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | 2026-09-24 | Traditional | PDF ↗ |
| K252723 | Dynamis Pro Family | Fotona D.O.O. | 2026-09-19 | Traditional | PDF ↗ |
| K241973 | SmartIPL_NI System | Lumenis Be, Ltd. | 2026-09-19 | Traditional | PDF ↗ |
| K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | 2026-09-18 | Traditional | PDF ↗ |
| K261673 | LED Therapy Device (QLXY-01) | Beijing Nubway S&T Co., Ltd. | 2026-09-17 | Traditional | PDF ↗ |
| K261817 | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-09-17 | Traditional | PDF ↗ |
| K262877 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | 2026-09-16 | Special | PDF ↗ |
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | 2026-09-10 | Traditional | PDF ↗ |
| K261562 | Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. | 2026-09-10 | Traditional | PDF ↗ |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-09-02 | Traditional | PDF ↗ |
| K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | 2026-09-01 | Traditional | PDF ↗ |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-08-27 | Traditional | PDF ↗ |
| K261964 | ECHOLASER X4 | Elesta S.P.A | 2026-08-19 | Traditional | PDF ↗ |
| K262070 | Diode Laser Therapy Systems (DL612A) | Hebei Zollvan Medical Technology Co., Ltd. | 2026-08-19 | Traditional | PDF ↗ |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | 2026-08-11 | Traditional | PDF ↗ |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | 2026-07-24 | Traditional | PDF ↗ |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026-07-21 | Traditional | PDF ↗ |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | 2026-07-17 | Traditional | PDF ↗ |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | 2026-07-16 | Traditional | PDF ↗ |
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | 2026-06-18 | Special | PDF ↗ |
| K261570 | PICOSURE WORKSTATION | Cynosure, LLC | 2026-06-17 | Special | PDF ↗ |
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | 2026-06-04 | Traditional | PDF ↗ |
| K260138 | LUNE PureHygiene | Enamel Pure | 2026-05-29 | Traditional | PDF ↗ |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | 2026-05-29 | Traditional | PDF ↗ |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | 2026-05-21 | Traditional | PDF ↗ |
| K260100 | MOSES Raydar | Boston Scientific Corporation | 2026-05-18 | Traditional | PDF ↗ |
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | 2026-05-11 | Special | PDF ↗ |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-05-07 | Traditional | PDF ↗ |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 | Traditional | PDF ↗ |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | Leaseir Technologies, Slu | 2026-05-04 | Traditional | PDF ↗ |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026-04-29 | Special | PDF ↗ |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | 2026-04-22 | Traditional | PDF ↗ |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-04-20 | Traditional | PDF ↗ |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | 2026-04-15 | Traditional | PDF ↗ |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-04-09 | Traditional | PDF ↗ |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | 2026-03-31 | Traditional | PDF ↗ |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | 2026-03-28 | Traditional | PDF ↗ |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | 2026-03-17 | Traditional | PDF ↗ |
| K260632 | LASER THERMAL THERAPY KIT | Elesta S.P.A | 2026-03-17 | Special | PDF ↗ |
| K254197 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | 2026-03-11 | Traditional | PDF ↗ |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-03-06 | Traditional | PDF ↗ |
| K253920 | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. | 2026-03-03 | Traditional | PDF ↗ |
| K253829 | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing HuaCheng Taike Technology Co., Ltd. | 2026-02-27 | Traditional | PDF ↗ |
| K253828 | Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) | Beijing HuaCheng Taike Technology Co., Ltd. | 2026-02-27 | Traditional | PDF ↗ |
| K254271 | CAPRI | ORO Co., Ltd. | 2026-02-26 | Traditional | PDF ↗ |
| K252599 | Diode Laser Therapy Systems (WLA-02) | Wingderm Electro-Optics , Ltd. | 2026-02-24 | Traditional | PDF ↗ |
| K252561 | BTL-754FF | BTL Industries, Inc. | 2026-02-18 | Traditional | PDF ↗ |
| K252048 | 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. | 2026-02-03 | Traditional | PDF ↗ |
| K251981 | Boston PICO (Boston PICO) | Boston Aesthetics, Inc. | 2026-01-30 | Traditional | PDF ↗ |
| K252753 | Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda | 2026-01-24 | Traditional | PDF ↗ |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-01-24 | Traditional | PDF ↗ |
| K252369 | Boston Pico755 | Boston Aesthetics, Inc. | 2026-01-21 | Traditional | PDF ↗ |
| K253342 | PICO-K | Speclipse, Inc. | 2025-12-24 | Traditional | PDF ↗ |
| K252877 | SANDRO Dual | Wontech Co., Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K251077 | JOULE 1064nm System and Accessories | Sciton, Inc | 2025-12-19 | Traditional | PDF ↗ |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U) | Sanhe Lefis Electronics Co., Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) | Micro-Energy Medical Technology Co., Ltd. | 2025-12-12 | Traditional | PDF ↗ |
| K252658 | Medical Diode Laser Systems (TR-B) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 2025-11-28 | Traditional | PDF ↗ |
| K253344 | BELLUS-Q | Speclipse, Inc. | 2025-11-25 | Traditional | PDF ↗ |
| K253219 | LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. | 2025-11-25 | Traditional | PDF ↗ |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-24 | Traditional | PDF ↗ |
| 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) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-24 | Traditional | PDF ↗ |
| K253123 | CuRAS hybrid | Classys, Inc. | 2025-11-20 | Traditional | PDF ↗ |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-20 | Traditional | PDF ↗ |
| K252564 | Medical Diode Laser Systems (VeinCure) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 2025-11-07 | Traditional | PDF ↗ |
| K252519 | CO2 Laser Therapy System (K106) | Hebei Keylaser Sci-Tech Co.,Ltd | 2025-11-07 | Traditional | PDF ↗ |
| K252515 | Q-Switched Nd:Yag laser (K690) | Hebei Keylaser Sci-Tech Co.,Ltd | 2025-11-06 | Traditional | PDF ↗ |
| K251303 | Tamburo Thulium Fiber Laser System | Menovex Medical Technology (Shenzhen) Co., Ltd. | 2025-11-04 | Traditional | PDF ↗ |
| K252427 | Diode Laser Hair Removal Machine (GLD01) | Sanhe Meditech Co., Ltd. | 2025-10-31 | Traditional | PDF ↗ |
| K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | Boston Scientific Corporation | 2025-10-30 | Traditional | PDF ↗ |
| K251824 | Patriot Duo | Patriot Laser, LLC | 2025-10-27 | Traditional | PDF ↗ |
| K253100 | MultiPulse TFL | Asclepion Laser Technologies GmbH | 2025-10-23 | Special | PDF ↗ |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-10-23 | Traditional | PDF ↗ |
| K252345 | Picosecond Laser Device (PF131-BI) | Risu Medical Technology Co., Ltd. | 2025-10-23 | Traditional | PDF ↗ |
| K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. | 2025-10-20 | Traditional | PDF ↗ |
| K250776 | Lithoblast Single Use Holmium Laser Fibers | Dawell Medical, LLC | 2025-10-14 | Traditional | PDF ↗ |
| K251699 | The Botticelli (Model: Athena) | Bellamia Technologies, Inc. | 2025-10-08 | Traditional | PDF ↗ |
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) | Jeisys Medical Incorporated | 2025-10-03 | Traditional | PDF ↗ |
| K242946 | HESTIA (L200-A) | Senbitec Co., Ltd. | 2025-10-03 | Traditional | PDF ↗ |
| K252447 | Picosecond laser device (BMPS4) | Hebei Newangie Technology Co., Ltd. | 2025-10-01 | Traditional | PDF ↗ |
| K251919 | Thulium Laser System (Deluxlase) | Nanjing Bestview Laser S&T Co., Ltd. | 2025-09-26 | Traditional | PDF ↗ |
| K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) | Wuhan Dimed Laser Technology Co., Ltd. | 2025-09-25 | Traditional | PDF ↗ |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories | Alma Lasers, Inc. | 2025-09-24 | Traditional | PDF ↗ |
| K251100 | IPGTFL-02 | Ipg Medical Corporation | 2025-09-19 | Traditional | PDF ↗ |
| K242859 | VEGA | Ibramed Equipamentos Médicos | 2025-09-19 | Traditional | PDF ↗ |
| K251457 | Diode laser therapy device (VADER) | Beijing Superlaser Technology Co., Ltd. | 2025-09-03 | Traditional | PDF ↗ |
| K251727 | GLAM LED Facial Mask (TB-2386F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2025-08-29 | Traditional | PDF ↗ |
| K250261 | Heager Medical Laser Family (Sabrina/Adolf) | Heager GmbH | 2025-08-26 | Traditional | PDF ↗ |
| K251801 | Diode laser device (BM091) | Hebei Newangie Technology Co., Ltd. | 2025-08-08 | Traditional | PDF ↗ |
| K251432 | Olo | El.En S.P.A. | 2025-08-06 | Traditional | PDF ↗ |
| K251076 | Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) | Shenzhen Lifotronic Technology Co., Ltd. | 2025-07-30 | Traditional | PDF ↗ |
| K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-07-25 | Traditional | PDF ↗ |
| K250504 | Leonardo Duster | Ceramoptec GmbH | 2025-07-14 | Abbreviated | PDF ↗ |
| K251149 | AviClear Laser System | Cutera, Inc. | 2025-07-11 | Traditional | PDF ↗ |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers | Boston Scientific Corporation | 2025-07-09 | Special | PDF ↗ |
| K250165 | Pastelle | Wontech Co., Ltd. | 2025-07-03 | Traditional | PDF ↗ |
| K243701 | AuroLase® System | Nanospectra Biosciences, Inc. | 2025-07-02 | Traditional | PDF ↗ |
| K251049 | SurgiLight 1470 Diode Laser System (Model:Halo) | Micro-Energy Medical Technology Co., Ltd. | 2025-07-02 | Traditional | PDF ↗ |
| K251329 | Diode laser device (RF3120-BI) | Risu Medical Technology Co., Ltd. | 2025-06-27 | Traditional | PDF ↗ |
| K251632 | Optimas MAX System | InMode , Ltd. | 2025-06-26 | Special | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.