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#
- 3020611964
- 3016746323
- 2245304
- 3008720474
- 3011555967
- 3010511300
- 3015529593
- 3011743768
- 3005350457
- 3008729892
- 3031233199
- 3017400436
- 1313525
- 3010220595
- 3013734919
- 3012125201
- 3026400760
- 3007549439
- 1000391004
- 3043012074
- 3010359222
- 3012289707
- 3004884150
- 3012799115
- 2032513
- 3021550489
- 8030392
- 3014222368
- 8030115
- 3009039068
- 3017124433
- 3034246188
- 3005205318
- 3009593803
- 3018116888
- 3043127589
- 3012294783
- 1035236
- 3017065670
- 1319211
- 3005791808
- 3016170453
- 3016661372
- 1219930
- 1820334
- 1043653
- 3006247712
- 3011644607
- 3013121972
- 3005987567
- 2939653
- 2953684
- 3005282635
- 3006716777
- 3004940677
- 3027725665
- 3013557562
- 3010175098
- 3011657089
- 3031944951
- 3009746061
- 3034630389
- 3010933841
- 3005180774
- 3011024620
- 3006546131
- 3016076698
- 3008805497
- 3027619554
- 3009970070
- 3030418454
- 1216677
- 8043564
- 3016445722
- 3004378299
- 3016413636
- 3043729119
- 3013503862
- 3004642415
Source Documents#
Other 510(k) Records For Product Code GEX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | 2026-05-29 |
| K260138 | LUNE PureHygiene | Enamel Pure | 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 |
| 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 |