The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Nd:yag Laser Systems (various Models).
Device ID | K910805 |
510k Number | K910805 |
Device Name: | ND:YAG LASER SYSTEMS (VARIOUS MODELS) |
Classification | Laser, Ophthalmic |
Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
Contact | Lisa Mcgrath |
Correspondent | Lisa Mcgrath HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-26 |
Decision Date | 1991-05-24 |