510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K983797Substantially Equivalent

D.o.r.c. Harmony Total Vitrectomy System

Dutch Ophthalmic USA, Inc., Kingston NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983797 is the FDA 510(k) clearance record for D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM, a class II device, cleared for Dutch Ophthalmic USA, Inc. on under FDA product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered). FDA records list 10 510(k) clearances for Dutch Ophthalmic USA, Inc., from to . As of , FDA records show no recalls naming K983797.

Clearance record

Decision date
Received
(126 days to decision)
Product code
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Applicant
Dutch Ophthalmic USA, Inc. One Little River Rd., Kingston NH
510(k) summary
Summary
Third party review
No

Clearances, product code HQE

Trailing 12 months

FDA records hold no clearances under product code HQE in the trailing twelve months.

FDA records show no clearances under product code HQE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260