FDA 510(k) ClearanceGEX
Diode Laser Hair Removal Machine (GLD01)
FDA 510(k) K252427 · Sanhe Meditech Co., Ltd.
- 510(k) number
- K252427
- Device name
- Diode Laser Hair Removal Machine (GLD01)
- Applicant
- Sanhe Meditech Co., Ltd.
- Product code
- GEX
- Decision
- Substantially Equivalent
- Decision date
- 2025-10-31
- Device class
- Class 2
- Regulation number
- 878.4810
- Advisory committee
- General, Plastic Surgery
- Medical specialty
- General, Plastic Surgery
Candidate predicate devices
Other devices cleared under product code GEX — the same regulatory device type, and therefore candidate predicates for a substantial-equivalence comparison. Confirm each predicate is legally marketed before relying on it.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | 2026-06-04 |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | 2026-05-29 |
| K260138 | LUNE PureHygiene | Enamel Pure | 2026-05-29 |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | 2026-05-21 |
| K260100 | MOSES Raydar | Boston Scientific Corporation | 2026-05-18 |
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | 2026-05-11 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-05-07 |
| 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 |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026-04-29 |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | 2026-04-22 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-04-20 |
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.