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510(k) K170183

Cetus system, Cetus probe by A.R.C Laser GmbH — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2017
Date Received
January 23, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by A.R.C Laser GmbH

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  • K091059 — FOXQ 980 LASER (August 13, 2009)
  • K073322 — FOX 1-980, FOX Q-1064, FOX-Q-810 (February 22, 2008)

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  • K121675 — VERSAVIT (June 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)
  • K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE) (April 29, 2002)