510(k) K242191
- Device
- SOLTIVE? Laser System (SOLTIVE? Pro SuperPulsed Laser, SOLTIVE? Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- Applicant
- Olympus Surgical Technologies America
- 510(k) number
- K242191
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-23
- Date received
- 2024-07-25
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Apurva Joshi
- Address
- 800 W. Park Dr. Westborough MA US 01581 01581
FDA Registration Numbers#
- 3013376016
- 3042262496
- 2125050
- 3017264244
- 3025104654
- 1222773
- 3005545844
- 3037966040
- 3008393409
- 3010175098
- 3010027944
- 3006807694
- 3041275224
- 3033884002
- 3006368133
- 3043149902
- 1647149
- 3003477135
- 3011050570
- 3038372243
- 3004361445
- 3005238200
- 3013602304
- 3015976667
- 2528981
- 3014980461
- 3019906161
- 3002806603
- 3004633032
- 3011302631
- 3038356864
- 3008872264
- 1225072
- 3020770009
- 3017786046
- 3018094310
- 3043047259
- 9612448
- 3014561425
- 3012125201
- 3003610527
- 3017200975
- 3005282635
- 3006580954
- 3034246188
- 3003542872
- 3012452798
- 3039935725
- 2916735
- 1221275
- 3027725665
- 3033715699
- 3010060157
- 2529392
- 3008720474
- 3033511105
- 1000391004
- 3004450661
- 1423662
- 3004111573
- 1000393132
- 3016496662
- 3017400436
- 3002991496
- 3012440264
- 3003610374
- 1060848
- 3036240802
- 1313525
- 3007181527
- 3005580113
- 3006695864
- 3021349626
- 3002807715
- 3006546082
- 3011670002
- 9615030
- 3014388884
- 3004505220
Source Documents#
Other 510(k) Records For Product Code GEX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |