The following data is part of a premarket notification filed by Intralase Corp. with the FDA for Intralase Fusion Laser.
| Device ID | K063682 |
| 510k Number | K063682 |
| Device Name: | INTRALASE FUSION LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INTRALASE CORP. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Contact | Judy Gordon |
| Correspondent | Judy Gordon INTRALASE CORP. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-11 |
| Decision Date | 2007-02-09 |
| Summary: | summary |