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FDA 510(k)

OCULIGHT GL

K-Number: K960971 · 1996-08-28

ApplicantIriderm Div.
Decision Date1996-08-28
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCULIGHT GL is the device name listed in this FDA 510(k) record. The listed applicant is Iriderm Div.. It received FDA 510(k) clearance on 1996-08-28 under 510(k) number K960971. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCULIGHT GL?

OCULIGHT GL is a medical device that received FDA 510(k) clearance on 1996-08-28. The listed applicant is Iriderm Div.. The 510(k) number is K960971.

When did OCULIGHT GL receive FDA 510(k) clearance?

OCULIGHT GL received FDA 510(k) clearance on 1996-08-28, under 510(k) number K960971.

Who is the listed applicant for OCULIGHT GL?

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 OCULIGHT GL?

The FDA product code for OCULIGHT GL is HQF.

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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 532K960522DIOPEXY PROBEK915236IRIS G-PROBEK933211D'AMICO\PEYMAN FLUTED ENDOPROBEK922663IRIS OCULIGHT SLK913430IRIS OCULIGHT(R) SLX

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Related Devices (Code: HQF)

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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