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510(k) K170322

Catalys Precision Laser System by Abbott Medical Optics, Inc. — Product Code OOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2017
Date Received
February 1, 2017
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 Abbott Medical Optics, Inc.

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  • K133115 — COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGL (February 27, 2014)
  • K121721 — LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) (October 15, 2012)
  • K113151 — IFS LASER SYSTEM (March 8, 2012)
  • K111446 — SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM (December 21, 2011)
  • K111882 — LAMINAR FLOW PHACO TIPS (November 7, 2011)
  • K111697 — AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (September 27, 2011)

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