510(k) K221306
- Device
- SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
- Applicant
- Gyrus Acmi, Inc.
- 510(k) number
- K221306
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-27
- Date received
- 2022-05-05
- 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
- No
Applicant Contact#
- Contact
- Jon Gilber
- Address
- 800 W. Park Dr. Westborough MA US 01581 01581
FDA Registration Numbers#
- 3008915316
- 3013557562
- 3016405041
- 3023850562
- 1318319
- 3042953831
- 3014226003
- 3027605507
- 3015313684
- 3042641021
- 2031934
- 3019252665
- 3011964664
- 3033905238
- 3010363436
- 3013602304
- 3010314781
- 3011644607
- 3017786046
- 3003015433
- 3015452693
- 3003616071
- 3016453004
- 2953684
- 8040564
- 1000523114
- 3032916575
- 3009746061
- 3015807001
- 3021334828
- 3012980277
- 3023344923
- 3012911444
- 8010720
- 3014388884
- 9614977
- 2134812
- 2032092
- 3013532143
- 3014980461
- 3017060146
- 3003708273
- 3033715699
- 1018470
- 3043140693
- 3032147807
- 3046005941
- 3012125201
- 3010972758
- 3033126947
- 3017200975
- 3025268687
- 3030418454
- 2939653
- 3010027944
- 3015167792
- 3008206114
- 3014225468
- 2529392
- 3025379728
- 3004096429
- 3010273372
- 3012799115
- 3003082988
- 3011743768
- 3038372243
- 3037874486
- 3010707607
- 3011302631
- 3017181358
- 3006580954
- 3007674911
- 3043657394
- 2953696
- 3022327202
- 3043153468
- 3003340844
- 3042228064
- 3027851853
- 3011877721
Source Documents#
Other 510(k) Records For Product Code GEX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K261221 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | 2026-07-24 |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026-07-21 |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | 2026-07-17 |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | 2026-07-16 |
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | 2026-06-18 |
| K261570 | PICOSURE WORKSTATION | Cynosure, LLC | 2026-06-17 |
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | 2026-06-04 |
| K260138 | LUNE PureHygiene | Enamel Pure | 2026-05-29 |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | 2026-05-29 |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | 2026-05-21 |
| K260100 | MOSES Raydar™ | Boston Scientific Corporation | 2026-05-18 |