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510(k) K121187

KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES by Katalyst Surgical, LLC — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2012
Date Received
April 19, 2012
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

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