510(k) K251329
- Device
- Diode laser device (RF3120-BI)
- Applicant
- Risu Medical Technology Co., Ltd.
- 510(k) number
- K251329
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-27
- Date received
- 2025-04-30
- 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) Intercection Of Kangding Rd. And Tongwen Rd. Fengxi New City Of Xixian New Area CN 712000 712000
FDA Registration Numbers#
- 3033273466
- 1221275
- 3021550489
- 3014225468
- 3005855240
- 3026668625
- 3010902869
- 3006082230
- 3002991496
- 3004378299
- 3006546082
- 3004884150
- 9614977
- 3043729119
- 3012157621
- 3004642415
- 3012322232
- 3020900954
- 9611516
- 3011782009
- 3006555617
- 3014388884
- 3010933841
- 3009298127
- 3019252665
- 3041275224
- 3023808190
- 3009453258
- 3020770009
- 3010273872
- 2529392
- 3034630389
- 3012125201
- 3016170453
- 3033511105
- 8043792
- 3011310540
- 2939653
- 3033884002
- 3006985208
- 3013503862
- 3002807715
- 3021334828
- 3048506982
- 2183744
- 3004135191
- 3011302631
- 2936921
- 8040564
- 3036425107
- 2125050
- 3010912900
- 3009736547
- 3010822033
- 3030125922
- 3010202439
- 8030987
- 2018957
- 3004858034
- 3014342096
- 3042953831
- 9611388
- 3005730446
- 3043047259
- 3011024620
- 3008206114
- 3044905918
- 3006849754
- 1225072
- 3007731000
- 3037874486
- 3017954802
- 3031233197
- 3015077548
- 3008627763
- 3008872264
- 9612147
- 8030885
- 3003477135
Source Documents#
Other 510(k) Records For Product Code GEX#
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|---|---|---|---|
| K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | 2026-09-24 |
| K241973 | SmartIPL_NI System | Lumenis Be, Ltd. | 2026-09-19 |
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| K262877 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | 2026-09-16 |
| K261562 | Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. | 2026-09-10 |
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| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-09-02 |
| K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | 2026-09-01 |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-08-27 |
| K261964 | ECHOLASER X4 | Elesta S.P.A | 2026-08-19 |
| K262070 | Diode Laser Therapy Systems (DL612A) | Hebei Zollvan Medical Technology Co., Ltd. | 2026-08-19 |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | 2026-08-11 |