510(k) K260974
- Device
- CO2 Laser Machine (Monica-I,Monica-II)
- Applicant
- Nanjing Bestview Laser S&T Co., Ltd.
- 510(k) number
- K260974
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-07
- Date received
- 2026-03-24
- 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
- Jing Wang
- Address
- 1st & 2nd Floor, Bldg. 5, Area 1, Phase 2, Liandong U Valley Nanjing CN 210000 210000
FDA Registration Numbers
- 3038715747
- 1725006
- 3018116888
- 3013917867
- 3023344923
- 3030495752
- 1054713
- 3030233762
- 3011657089
- 3010060157
- 1221275
- 3012452798
- 3019906161
- 2438558
- 2183744
- 3020611964
- 2939653
- 3009039068
- 3030230686
- 3008805497
- 1216677
- 3005801723
- 3003610374
- 2938071
- 3032916575
- 1313525
- 3011050570
- 3003015433
- 3013376016
- 3015392301
- 3020770009
- 8044098
- 2027755
- 3009488834
- 3011302631
- 3008442971
- 1064858
- 1225072
- 3002807314
- 1045254
- 1419489
- 3017124433
- 3043011436
- 3030733800
- 3004378299
- 3013602304
- 8021543
- 8040564
- 3016453004
- 3007336385
- 3043047259
- 3009649442
- 1723170
- 1226486
- 3017200975
- 3011743768
- 3013041594
- 3006368133
- 3015313684
- 3029083714
- 3014561425
- 3036240802
- 3016413636
- 3008915316
- 3016170453
- 3021550489
- 3009298127
- 3014980477
- 3005210579
- 2032112
- 3016830208
- 2954354
- 3011670002
- 9610617
- 3034630389
- 3009462521
- 3008925277
- 2953684
- 3042261306
Source Documents
Other 510(k) Records For Product Code GEX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | 2026-05-11 |
| 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 |
| 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 |
| K254197 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | 2026-03-11 |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-03-06 |
| K253920 | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. | 2026-03-03 |