The following data is part of a premarket notification filed by Surgical Laser Incorporated with the FDA for Sli Endoprobe, Sli Dent Bare Fiber, Sli Ho Bare Fiber, Sli Hcs Bare Fiber, Sli Lateral Firing Fiber.
| Device ID | K151855 |
| 510k Number | K151855 |
| Device Name: | SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGICAL LASER INCORPORATED SUITE 337 7950 NW 53RD STREET Miami, FL 33166 |
| Contact | Gordon Willox |
| Correspondent | F. Kettenbaum F. KETTENBAUM LTD. TAL-BONZU - TRIQ L - IMGHAZEL Swieqi, MT Swq 3141 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-08 |
| Decision Date | 2016-04-15 |
| Summary: | summary |