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510(k) K983797

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

K983797 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic USA, Inc. for the device "D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 3, 1999. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Dutch Ophthalmic USA, Inc. has at least 9 other 510(k) clearances on record.

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

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • 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)

FDA data resources