SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, And Accessories)
Powered Laser Surgical Instrument
Olympus Surgical Technologies America
The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Soltive™ Laser System(soltive™ Pro Superpulsed Laser, Soltive™ Premium Superpulsed Laser, Soltive™laser Fibers, And Accessories).
Pre-market Notification Details
| Device ID | K183647 |
| 510k Number | K183647 |
| Device Name: | SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, And Accessories) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
| Contact | Jon Gilbert |
| Correspondent | Jon Gilbert Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-08-09 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925044586 | K183647 | 000 |
| 00821925044111 | K183647 | 000 |
| 00821925044135 | K183647 | 000 |
| 00821925044258 | K183647 | 000 |
| 00821925044272 | K183647 | 000 |
| 00821925044302 | K183647 | 000 |
| 00821925044340 | K183647 | 000 |
| 00821925044388 | K183647 | 000 |
| 00821925044401 | K183647 | 000 |
| 00821925044425 | K183647 | 000 |
| 00821925044449 | K183647 | 000 |
| 00821925044463 | K183647 | 000 |
| 00821925044487 | K183647 | 000 |
| 00821925044500 | K183647 | 000 |
| 00821925044593 | K183647 | 000 |
| 00821925044609 | K183647 | 000 |
| 00821925044616 | K183647 | 000 |
| 00821925044036 | K183647 | 000 |
Trademark Results [SOLTIVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLTIVE 88270800 not registered Live/Pending |
Olympus Corporation 2019-01-22 |
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