The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Unipulse Co2 Surgical Laser System.
Device ID | K980475 |
510k Number | K980475 |
Device Name: | UNIPULSE CO2 SURGICAL LASER SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
Contact | Ken Kato |
Correspondent | Ken Kato NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-06 |
Decision Date | 1998-12-16 |
Summary: | summary |