Cleared Traditional

K983797 - D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM

K983797 is an FDA 510(k) clearance for D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM, manufactured by Dutch Ophthalmic USA, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K983797 · Dutch Ophthalmic USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
126d
Days
Class 2
Risk

K983797 is an FDA 510(k) clearance for the D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on March 3, 1999 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Dutch Ophthalmic USA, Inc. devices

FDA 510(k) Submission Details - K983797

510(k) Number K983797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1998
Decision Date March 03, 1999
Days to Decision 126 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 110d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQE Device Classification - Class 2, Special Controls

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 92
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K983797.
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