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#
- 3004096429
- 3010359222
- 2018957
- 3006786907
- 3003015433
- 8044098
- 3006716777
- 3009444646
- 3012157621
- 3009970070
- 3020221089
- 3004450661
- 3004884150
- 3040278125
- 3012289707
- 3007712511
- 3017181358
- 3011412640
- 3027725665
- 1018233
- 2936921
- 2032513
- 3021380980
- 3019559090
- 2953696
- 3010175098
- 3004633032
- 3015907115
- 3016661372
- 3034630389
- 3015262665
- 3002991496
- 3026668625
- 3004111573
- 3015779311
- 3017786046
- 3033126947
- 3004529369
- 3018188770
- 3011024620
- 3007084556
- 3038715747
- 3013446079
- 3016096097
- 3032916575
- 3015658550
- 3044995573
- 3025379728
- 3003082988
- 3046005941
- 3014980461
- 9611516
- 3014388884
- 3011423170
- 3018318562
- 3020756
- 3015392301
- 3009488834
- 3038197172
- 3008627763
- 3023850562
- 3001605696
- 8030885
- 1219930
- 3001431138
- 3002808227
- 3038356864
- 8030987
- 3003340844
- 1038823
- 3016076077
- 3020900954
- 3013613043
- 3008776882
- 9615030
- 3003168101
- 3021550489
- 3010902869
- 2011171
Source Documents#
Other 510(k) Records For Product Code GEX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | 2026-05-11 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-05-07 |
| 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 |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 |