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510(k) K170183

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

K170183 is an FDA 510(k) premarket notification submitted by A.R.C Laser GmbH for the device "Cetus system, Cetus probe". The FDA issued a decision of Substantially Equivalent on September 27, 2017. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. A.R.C Laser GmbH has at least 5 other 510(k) clearances on record.

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

  • K220531 — FOX 810, FOX 980 (September 1, 2022)
  • K192272 — Wolf445nm (March 17, 2020)
  • K161403 — A.R.C. Laser Surgical Fibers and Probes (August 16, 2016)
  • K091059 — FOXQ 980 LASER (August 13, 2009)
  • K073322 — FOX 1-980, FOX Q-1064, FOX-Q-810 (February 22, 2008)

Other clearances for product code HQE

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • 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)

FDA data resources