The following data is part of a premarket notification filed by Lasag Ag with the FDA for Lasag Microrupter 2 Nd:yag Laser Trabeculoplasty.
Device ID | K900199 |
510k Number | K900199 |
Device Name: | LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY |
Classification | Laser, Ophthalmic |
Applicant | LASAG AG 500 IOLAB DR. Claremont, CA 91711 |
Contact | Shelley Beadle |
Correspondent | Shelley Beadle LASAG AG 500 IOLAB DR. Claremont, CA 91711 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-16 |
Decision Date | 1990-03-27 |