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510(k) K983797

D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM by Dutch Ophthalmic USA, Inc. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1999
Date Received
October 28, 1998
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 Dutch Ophthalmic USA, Inc.

  • K012821 — D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM (October 22, 2001)
  • K010082 — D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (March 12, 2001)
  • K980636 — FIBER OPTIC ENDOILLUMINATION PROBE (May 20, 1998)
  • K973229 — D.O.R.C. HEXON ILLUMINATION SYSTEM (November 25, 1997)
  • K973757 — D.O.R.C. SOLUX LIGHT SOURCE (November 7, 1997)
  • K962135 — D.O.R.C. MICRODIATHERMY SYSTEM (August 29, 1996)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K940373 — OPHTHALMIC CRYO UNIT (July 18, 1994)
  • K902491 — ECKHARDT TEMPORARY KERATOPROSTHESIS (June 26, 1990)

Other clearances for product code HQE

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  • K170183 — Cetus system, Cetus probe (September 27, 2017)
  • 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)