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510(k) K132534

VICTUS FEMTOSECOND LASER PLATFORM by Technolas Perfect Vision GmbH — Product Code OOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2014
Date Received
August 13, 2013
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 Technolas Perfect Vision GmbH

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  • K171014 — VICTUS Femtosecond Laser Platform (October 19, 2017)
  • K151161 — VICTUS Femtosecond Laser Platform (June 24, 2015)
  • K141379 — VICTUS FEMTOSECOND LASER PLATFORM (January 16, 2015)
  • K140615 — VICTUS FEMTOSECOND LASER PLATFORM (July 15, 2014)
  • K122386 — VICTUS FEMTOSECOND LASER PLATFORM (February 8, 2013)
  • K120426 — VICTUS LASER PLATFORM (July 31, 2012)
  • K110427 — FEMTEC LASER SYSTEM FOR CAPSULOTOMY (November 22, 2011)
  • K984443 — ORBSCAN (March 5, 1999)

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