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FDA 510(k)

IRIS OCULIGHT(R) SLX

K-Number: K913430 · 1991-11-15

ApplicantIriderm Div.
Decision Date1991-11-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IRIS OCULIGHT(R) SLX is the device name listed in this FDA 510(k) record. The listed applicant is Iriderm Div.. It received FDA 510(k) clearance on 1991-11-15 under 510(k) number K913430. 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 IRIS OCULIGHT(R) SLX?

IRIS OCULIGHT(R) SLX is a medical device that received FDA 510(k) clearance on 1991-11-15. The listed applicant is Iriderm Div.. The 510(k) number is K913430.

When did IRIS OCULIGHT(R) SLX receive FDA 510(k) clearance?

IRIS OCULIGHT(R) SLX received FDA 510(k) clearance on 1991-11-15, under 510(k) number K913430.

Who is the listed applicant for IRIS OCULIGHT(R) SLX?

The FDA 510(k) record lists Iriderm Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRIS OCULIGHT(R) SLX?

The FDA product code for IRIS OCULIGHT(R) SLX is GEX. This falls under the Gastroenterology category.

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Other records listing Iriderm Div. 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.

K964074DIOLITE 532K960971OCULIGHT GLK960522DIOPEXY PROBEK915236IRIS G-PROBEK933211D'AMICO\PEYMAN FLUTED ENDOPROBEK922663IRIS OCULIGHT SL

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Related Devices (Code: GEX)

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.

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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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