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FDA 510(k)

DI-RHEX OPHTHALMIC DIATHERMY SYSTEM

K-Number: K990064 · 1999-04-04

ApplicantOphthalmic Technologies, Inc.
Decision Date1999-04-04
Product CodeHQR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DI-RHEX OPHTHALMIC DIATHERMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmic Technologies, Inc.. It received FDA 510(k) clearance on 1999-04-04 under 510(k) number K990064. The device is classified under product code HQR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DI-RHEX OPHTHALMIC DIATHERMY SYSTEM?

DI-RHEX OPHTHALMIC DIATHERMY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-04-04. The listed applicant is Ophthalmic Technologies, Inc.. The 510(k) number is K990064.

When did DI-RHEX OPHTHALMIC DIATHERMY SYSTEM receive FDA 510(k) clearance?

DI-RHEX OPHTHALMIC DIATHERMY SYSTEM received FDA 510(k) clearance on 1999-04-04, under 510(k) number K990064.

Who is the listed applicant for DI-RHEX OPHTHALMIC DIATHERMY SYSTEM?

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

What is the FDA product code for DI-RHEX OPHTHALMIC DIATHERMY SYSTEM?

The FDA product code for DI-RHEX OPHTHALMIC DIATHERMY SYSTEM is HQR.

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Other records listing Ophthalmic Technologies, Inc. as applicant

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.

K042885OCT-OPTHALMOSCOPEK031391HF MODULE WITH TRANSDUCERSK030770OTI SCAN WITH TRANSDUCERSK024114A-SCAN 100K9745223D I-SCANK971679I-SCOPE OPHTHALMIC ENDOSCOPE

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Related Devices (Code: HQR)

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.

K050308THERMAL CAUTERY PROBEStarion InstrumentsK980522REFRACTEC MCS-100Refractec, Inc.K972749PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)C.M. Chance , Ltd.K952151STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)StorzK955158SURGITRONEllman Intl., Inc.K952569GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATORGamp & Assoc.

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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