Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GEX — Predicate Candidate Screening
2,872 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
252 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261221 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTI | Olympus Surgical Technologies America | 2026-07-24 | 101 | 0 |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026-07-21 | 55 | 0 |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | 2026-07-17 | 56 | 0 |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | 2026-07-16 | 56 | 0 |
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40- | Micro-Energy Medical Technology Co., Ltd. | 2026-06-18 | 27 | 0 |
| K261570 | PICOSURE WORKSTATION | Cynosure, LLC | 2026-06-17 | 36 | 0 |
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | 2026-06-04 | 93 | 0 |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | 2026-05-29 | 105 | 0 |
| K260138 | LUNE PureHygiene | Enamel Pure | 2026-05-29 | 133 | 0 |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | 2026-05-21 | 234 | 0 |
| K260100 | MOSES Raydar™ | Boston Scientific Corporation | 2026-05-18 | 125 | 0 |
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | 2026-05-11 | 27 | 0 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-05-07 | 44 | 0 |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810 | Leaseir Technologies, Slu | 2026-05-04 | 217 | 0 |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 | 96 | 0 |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026-04-29 | 27 | 0 |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | 2026-04-22 | 148 | 0 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-04-20 | 90 | 0 |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | 2026-04-15 | 75 | 0 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-04-09 | 94 | 0 |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | 2026-03-31 | 54 | 0 |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | 2026-03-28 | 59 | 0 |
| K252971 | Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fi | C.R. Bard, Inc. | 2026-03-17 | 181 | 0 |
| K260632 | LASER THERMAL THERAPY KIT | Elesta S.P.A | 2026-03-17 | 19 | 0 |
| K254197 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | 2026-03-11 | 78 | 0 |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Th | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-03-06 | 86 | 0 |
| K253920 | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. | 2026-03-03 | 85 | 0 |
| K253829 | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing HuaCheng Taike Technology Co., Ltd. | 2026-02-27 | 88 | 0 |
| K253828 | Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) | Beijing HuaCheng Taike Technology Co., Ltd. | 2026-02-27 | 88 | 0 |
| K254271 | CAPRI | ORO Co., Ltd. | 2026-02-26 | 58 | 0 |
| K252599 | Diode Laser Therapy Systems (WLA-02) | Wingderm Electro-Optics , Ltd. | 2026-02-24 | 190 | 0 |
| K252561 | BTL-754FF | BTL Industries, Inc. | 2026-02-18 | 189 | 0 |
| K252048 | 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. | 2026-02-03 | 218 | 0 |
| K251981 | Boston PICO (Boston PICO) | Boston Aesthetics, Inc. | 2026-01-30 | 217 | 0 |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-01-24 | 66 | 0 |
| K252753 | Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda | 2026-01-24 | 148 | 0 |
| K252369 | Boston Pico755 | Boston Aesthetics, Inc. | 2026-01-21 | 175 | 0 |
| K253342 | PICO-K | Speclipse, Inc. | 2025-12-24 | 85 | 0 |
| K252877 | SANDRO Dual | Wontech Co., Ltd. | 2025-12-19 | 100 | 0 |
| K251077 | JOULE 1064nm System and Accessories | Sciton, Inc | 2025-12-19 | 255 | 0 |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U) | Sanhe Lefis Electronics Co., Ltd. | 2025-12-19 | 262 | 0 |
| K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R | Micro-Energy Medical Technology Co., Ltd. | 2025-12-12 | 105 | 0 |
| K252658 | Medical Diode Laser Systems (TR-B) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 2025-11-28 | 98 | 0 |
| K253344 | BELLUS-Q | Speclipse, Inc. | 2025-11-25 | 56 | 0 |
| K253219 | LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. | 2025-11-25 | 57 | 0 |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Po | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-24 | 83 | 0 |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser Syst | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-24 | 83 | 0 |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fibe | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-20 | 62 | 0 |
| K253123 | CuRAS hybrid | Classys, Inc. | 2025-11-20 | 56 | 0 |
| K252564 | Medical Diode Laser Systems (VeinCure) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 2025-11-07 | 85 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda