The following data is part of a premarket notification filed by Cyden Limited with the FDA for Modification To Ifl Professional System, Model C100.
| Device ID | K050165 |
| 510k Number | K050165 |
| Device Name: | MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYDEN LIMITED TECHNIUM, KINGS ROAD THE DOCKS Swansea, Wales, GB Sa1 8ph |
| Contact | Michael Noel Kiernan |
| Correspondent | Michael Noel 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-25 |
| Decision Date | 2005-04-19 |
| Summary: | summary |