The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Fidelis Plus Iii D, At Fidelis D, Powerlase At D / Fidelis Plus Iii, At Fidelis, Powerlase At / Fidelis Er Iii D, Ht Fid.
| Device ID | K093162 |
| 510k Number | K093162 |
| Device Name: | FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FOTONA D.D. STEGNE 7, Ljubljana, SI 1210 |
| Contact | Stojan Trost |
| Correspondent | Stojan Trost FOTONA D.D. STEGNE 7, Ljubljana, SI 1210 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-06 |
| Decision Date | 2010-01-22 |
| Summary: | summary |