The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon(r) Fx2(tm) Photocoagulator.
| Device ID | K914334 |
| 510k Number | K914334 |
| Device Name: | ALCON(R) FX2(TM) PHOTOCOAGULATOR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | David Krapf |
| Correspondent | David Krapf ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-27 |
| Decision Date | 1992-11-13 |