The following data is part of a premarket notification filed by Intralase Corp. with the FDA for Ifs Laser System.
| Device ID | K073404 |
| 510k Number | K073404 |
| Device Name: | IFS LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INTRALASE CORP. 5 GRINDLAY PL Aliso Viejo, CA 92656 |
| Contact | Maureen Weiner |
| Correspondent | Maureen Weiner INTRALASE CORP. 5 GRINDLAY PL Aliso Viejo, CA 92656 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-04 |
| Decision Date | 2008-04-25 |
| Summary: | summary |