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FDA 510(k)

ELIOS DIODE OPHTHALMIC LASER

K-Number: K921320 · 1992-07-02

ApplicantMarco Ophthalmic, Inc.
Decision Date1992-07-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELIOS DIODE OPHTHALMIC LASER is the device name listed in this FDA 510(k) record. The listed applicant is Marco Ophthalmic, Inc.. It received FDA 510(k) clearance on 1992-07-02 under 510(k) number K921320. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELIOS DIODE OPHTHALMIC LASER?

ELIOS DIODE OPHTHALMIC LASER is a medical device that received FDA 510(k) clearance on 1992-07-02. The listed applicant is Marco Ophthalmic, Inc.. The 510(k) number is K921320.

When did ELIOS DIODE OPHTHALMIC LASER receive FDA 510(k) clearance?

ELIOS DIODE OPHTHALMIC LASER received FDA 510(k) clearance on 1992-07-02, under 510(k) number K921320.

Who is the listed applicant for ELIOS DIODE OPHTHALMIC LASER?

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

What is the FDA product code for ELIOS DIODE OPHTHALMIC LASER?

The FDA product code for ELIOS DIODE OPHTHALMIC LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Marco Ophthalmic, 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.

K943234MS-30 AUTOMATIC PERIMETERK930444MARCO STANDARD KERATOMETERSK930438MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPSK930437MARCO STANDARD RADIUSGAUGESK930442MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPSK930439MARCO SURGISCOPE OPERATION MICROSCOPES

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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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