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 |