The following data is part of a premarket notification filed by Intralase Corp. with the FDA for Intralase Fs Laser.
| Device ID | K031960 |
| 510k Number | K031960 |
| Device Name: | INTRALASE FS LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INTRALASE CORP. 9701 JERONIMO ROAD Irvine, CA 92618 |
| Contact | Charline Gauthier |
| Correspondent | Charline Gauthier INTRALASE CORP. 9701 JERONIMO ROAD Irvine, CA 92618 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-25 |
| Decision Date | 2003-09-29 |
| Summary: | summary |