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510(k) K901605

PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. by Phoenix Laser Systems, Inc. — Product Code LXS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 13, 1990
Date Received: April 5, 1990
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Device Class: Class II
Regulation Number: 886.4392
Review Panel: OP
Submission Type