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FDA 510(k)

CORNEAL LIGHT SHIELD

K-Number: K840834 · 1984-10-05

ApplicantGabl, Inc.
Decision Date1984-10-05
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CORNEAL LIGHT SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Gabl, Inc.. It received FDA 510(k) clearance on 1984-10-05 under 510(k) number K840834. The device is classified under product code HOY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNEAL LIGHT SHIELD?

CORNEAL LIGHT SHIELD is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Gabl, Inc.. The 510(k) number is K840834.

When did CORNEAL LIGHT SHIELD receive FDA 510(k) clearance?

CORNEAL LIGHT SHIELD received FDA 510(k) clearance on 1984-10-05, under 510(k) number K840834.

Who is the listed applicant for CORNEAL LIGHT SHIELD?

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

What is the FDA product code for CORNEAL LIGHT SHIELD?

The FDA product code for CORNEAL LIGHT SHIELD is HOY.

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Related Devices (Code: HOY)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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