D.O.R.C. Harmony Total Vitrectomy System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K983797 ↗

FDA Product Code

HQE

Device Class

Class II

Regulation

21 CFR Part 886.4150

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• D.O.R.C. Hexon Illumination System

  Class II

  FDA 510(k) K973229 Active Cleared 25 Nov 1997

• D.O.R.C. Microdiathermy System

  Class II

  FDA 510(k) K962135 Active Cleared 29 Aug 1996

• D.O.R.C. Vfi/Vfe System

  Class I

  FDA 510(k) K954842 Active Cleared 15 Apr 1996

• D.O.R.C. Solux Light Source

  Class II

  FDA 510(k) K973757 Active Cleared 7 Nov 1997

• D.O.R.C. CryoStar Cryosurgical System

  Class II

  FDA 510(k) K012821 Active Cleared 22 Oct 2001

• Fiber Optic Endoillumination Probe

  Class II

  FDA 510(k) K980636 Active Cleared 20 May 1998

See all devices from Dutch Ophthalmic USA, Inc. →