The following data is part of a premarket notification filed by Abbott Medical Optics Inc with the FDA for Ifs Laser System.
| Device ID | K113151 |
| 510k Number | K113151 |
| Device Name: | IFS LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ABBOTT MEDICAL OPTICS INC 1700 EAST SAINT ANDREW PL Santa Ana, CA 92705 |
| Contact | Kesley E Gallagher |
| Correspondent | Kesley E Gallagher ABBOTT MEDICAL OPTICS INC 1700 EAST SAINT ANDREW PL Santa Ana, CA 92705 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-25 |
| Decision Date | 2012-03-08 |
| Summary: | summary |