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FDA 510(k)

I-SCOPE OPHTHALMIC ENDOSCOPE

K-Number: K971679 · 1997-06-25

ApplicantOphthalmic Technologies, Inc.
Decision Date1997-06-25
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

I-SCOPE OPHTHALMIC ENDOSCOPE 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 1997-06-25 under 510(k) number K971679. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-SCOPE OPHTHALMIC ENDOSCOPE?

I-SCOPE OPHTHALMIC ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Ophthalmic Technologies, Inc.. The 510(k) number is K971679.

When did I-SCOPE OPHTHALMIC ENDOSCOPE receive FDA 510(k) clearance?

I-SCOPE OPHTHALMIC ENDOSCOPE received FDA 510(k) clearance on 1997-06-25, under 510(k) number K971679.

Who is the listed applicant for I-SCOPE OPHTHALMIC ENDOSCOPE?

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 I-SCOPE OPHTHALMIC ENDOSCOPE?

The FDA product code for I-SCOPE OPHTHALMIC ENDOSCOPE is MPA.

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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 100K990064DI-RHEX OPHTHALMIC DIATHERMY SYSTEMK9745223D I-SCAN

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Related Devices (Code: MPA)

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.

K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc.K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc.K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)Peregrine Surgical, LLCK221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical)K202670Nam illumination probe with chopperOculight , Ltd.K080067ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETERIscience Interventional

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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