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510(k) K210701

CATALYS Precision Laser System by Amo Manufacturing USA, LLC — Product Code OOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2021
Date Received
March 9, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.

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