The following data is part of a premarket notification filed by American Laser Medical with the FDA for Nuvolase 660 Laser System For Ophthalmology.
Device ID | K972561 |
510k Number | K972561 |
Device Name: | NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY |
Classification | Powered Laser Surgical Instrument |
Applicant | AMERICAN LASER MEDICAL 1832 SOUTH 3850 WEST Salt Lake City, UT 84104 |
Contact | Daniel Hoefer |
Correspondent | Daniel Hoefer AMERICAN LASER MEDICAL 1832 SOUTH 3850 WEST Salt Lake City, UT 84104 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-09 |
Decision Date | 1997-10-06 |
Summary: | summary |