510(k) K801336

MODEL 900K PHOTOCOAGULATOR by Coherent Medical Division — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
June 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type