The following data is part of a premarket notification filed by Intra Lase Corp. with the FDA for Intralase Fs Laser, Intralase Fs30 Laser, Models 1, 2, 3.
| Device ID | K060372 |
| 510k Number | K060372 |
| Device Name: | INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INTRA LASE CORP. 9701 JERONIMO ROAD Irvine, CA 92618 -1916 |
| Contact | Charline Gauthier |
| Correspondent | Charline Gauthier INTRA LASE CORP. 9701 JERONIMO ROAD Irvine, CA 92618 -1916 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-08-16 |
| Summary: | summary |