510(k) K252345
- Device
- Picosecond Laser Device (PF131-BI)
- Applicant
- Risu Medical Technology Co., Ltd.
- 510(k) number
- K252345
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-23
- Date received
- 2025-07-28
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tianqiang Yu
- Address
- Rm.201, Bldg. 11, Western Cloud Valley(Phase Iii), The Intercection Of Kangding Rd. And Tongwen Rd. Fengxi New City Of Xixian New Area CN 712000 712000
FDA Registration Numbers#
- 3009649442
- 3041275224
- 3026038437
- 3017638059
- 3006716777
- 3010053203
- 3011877721
- 8044098
- 3037047060
- 3033715699
- 2936921
- 3007583504
- 3002991496
- 3019705154
- 3011555967
- 3010202439
- 2938889
- 3006849754
- 2032513
- 3033482500
- 3042262496
- 3004483538
- 8040564
- 3008156177
- 3012772112
- 3030543531
- 3015658550
- 3026360847
- 9610617
- 3007535734
- 9611036
- 3009444646
- 3009593803
- 3009383334
- 3027605507
- 3027851853
- 3006555617
- 3010364538
- 3044905918
- 3008627763
- 3029897009
- 1054713
- 3007181527
- 3003542872
- 3013529876
- 3014561425
- 3008085016
- 9611388
- 3003708273
- 1018233
- 1725006
- 3031582430
- 3011782009
- 3022327202
- 3033274371
- 1222993
- 3037874486
- 2134812
- 2124215
- 9613462
- 1225450
- 3005580113
- 9612448
- 3011514163
- 3018318562
- 3006368133
- 3004450661
- 3009039068
- 3030233762
- 3021334828
- 3013619029
- 1216677
- 3010972758
- 3016746323
- 2953696
- 3011310540
- 3003168101
- 3001605696
- 3026668625
Source Documents#
Other 510(k) Records For Product Code GEX#
| 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 |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 |
| 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 |
| 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 |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | 2026-04-15 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-04-09 |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | 2026-03-31 |