Cleared Traditional

LASER PHOTOCOAGULATOR

K827819 · American Laser Corp. · Radiology
Jan 1983
Decision
80d
Days
Risk

About This 510(k) Submission

K827819 is an FDA 510(k) clearance for the LASER PHOTOCOAGULATOR, submitted by American Laser Corp. (Boulder, US). The FDA issued a Cleared decision on January 7, 1983, 80 days after receiving the submission on October 19, 1982. This device falls under the Radiology review panel.

Submission Details

510(k) Number K827819 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1982
Decision Date January 07, 1983
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class