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FDA 510(k)

D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM

K-Number: K010082 · 2001-03-12

ApplicantDutch Ophthalmic USA, Inc.
Decision Date2001-03-12
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dutch Ophthalmic USA, Inc.. It received FDA 510(k) clearance on 2001-03-12 under 510(k) number K010082. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM?

D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-12. The listed applicant is Dutch Ophthalmic USA, Inc.. The 510(k) number is K010082.

When did D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM receive FDA 510(k) clearance?

D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM received FDA 510(k) clearance on 2001-03-12, under 510(k) number K010082.

Who is the listed applicant for D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM?

The FDA 510(k) record lists Dutch Ophthalmic USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM?

The FDA product code for D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM is HQE.

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Other records listing Dutch Ophthalmic USA, Inc. as applicant

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K012821D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEMK983797D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEMK980636FIBER OPTIC ENDOILLUMINATION PROBEK973229D.O.R.C. HEXON ILLUMINATION SYSTEMK973757D.O.R.C. SOLUX LIGHT SOURCEK962135D.O.R.C. MICRODIATHERMY SYSTEM

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Related Devices (Code: HQE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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