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510(k) K121091

CATALYS PRECISION LASER SYSTEM by Optimedica Corporation — Product Code OOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2012
Date Received
April 10, 2012
Clearance Type
Traditional
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.

Other clearances by Optimedica Corporation

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  • K100019 — PASCAL STREAMLINE PHOTOCOAGULATOR (May 4, 2010)
  • K091666 — PASCAL PHOTOCOAGULATOR, PASCAL-US (July 15, 2009)
  • K081744 — PASCAL SYNTHESIS DELIVERY SYSTEM (September 9, 2008)
  • K062336 — OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE (October 19, 2006)

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