The following data is part of a premarket notification filed by Cyden Limited with the FDA for Ipulse, Model: I150.
| Device ID | K083748 |
| 510k Number | K083748 |
| Device Name: | IPULSE, MODEL: I150 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYDEN LIMITED TECHNIUM, KINGS ROAD THE DOCKS Swansea, Wales, GB Sa1 8ph |
| Contact | Michael Kiernan |
| Correspondent | Michael Kiernan CYDEN LIMITED TECHNIUM, KINGS ROAD THE DOCKS Swansea, Wales, GB Sa1 8ph |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-17 |
| Decision Date | 2009-02-02 |