The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Flourotron Master.
Device ID | K811153 |
510k Number | K811153 |
Device Name: | COHERENT FLOUROTRON MASTER |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | LUMENIS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-27 |
Decision Date | 1981-06-16 |