The following data is part of a premarket notification filed by Amo Manufacturing Usa, Llc with the FDA for Ifs Advanced Femtosecond Laser System.
| Device ID | K141852 |
| 510k Number | K141852 |
| Device Name: | IFS ADVANCED FEMTOSECOND LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AMO MANUFACTURING USA, LLC 510 COTTONWOOD DRIVE Milpitas, CA 95035 |
| Contact | Rodney Huang |
| Correspondent | Rodney Huang AMO MANUFACTURING USA, LLC 510 COTTONWOOD DRIVE Milpitas, CA 95035 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-09 |
| Decision Date | 2015-01-06 |
| Summary: | summary |