510(k) K251801
- Device
- Diode laser device (BM091)
- Applicant
- Hebei Newangie Technology Co., Ltd.
- 510(k) number
- K251801
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-08
- Date received
- 2025-06-12
- 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
Related Records
Applicant Contact
- Contact
- Ning Wang
- Address
- # 509, Taihang S. St., High-Tech Zone, Shijiazhuang City, Hebei Province Rm. 402, Bldg. A-5, Guoxietang Shijiazhuang CN 050035 050035
FDA Registration Numbers
- 3007336385
- 3029083714
- 3010511300
- 3014388884
- 3014980477
- 3021159346
- 3009887511
- 3027605646
- 3013404959
- 3008206114
- 3012639861
- 3026540840
- 3012133441
- 3009383334
- 3033524191
- 3031233197
- 3007674911
- 1043653
- 3017173524
- 3000313549
- 3044175602
- 3015730775
- 3007535734
- 1226486
- 2245304
- 1928237
- 3004475754
- 3013041594
- 3010314781
- 3014226003
- 9611388
- 3033884002
- 3011555967
- 1219930
- 3008729892
- 3006546131
- 3010912900
- 3039396569
- 1220477
- 3004069780
- 3011310540
- 9612147
- 3033715699
- 3030979014
- 2438558
- 3010273872
- 3012289707
- 3011024620
- 3005515469
- 3014222368
- 3023344923
- 3004858034
- 3004940677
- 3007689716
- 3008156177
- 9710340
- 1820334
- 3005855240
- 3013515803
- 3010683226
- 3031233199
- 3004135191
- 1420032
- 3022327202
- 3005791808
- 3003683459
- 3032916575
- 8043564
- 3030733800
- 3008085016
- 3007712511
- 3027851853
- 1424263
- 3005801723
- 3009462521
- 3026038437
- 3006786907
- 3001431138
- 3030979156
Source Documents
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| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | 2026-03-31 |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | 2026-03-28 |
| K260632 | LASER THERMAL THERAPY KIT | Elesta S.P.A | 2026-03-17 |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | 2026-03-17 |