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FDA 510(k)

MEGABEAM ENDOCULAR PROBE

K-Number: K935747 · 1994-04-01

ApplicantCeram Optec, Inc.
Decision Date1994-04-01
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MEGABEAM ENDOCULAR PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Ceram Optec, Inc.. It received FDA 510(k) clearance on 1994-04-01 under 510(k) number K935747. 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 MEGABEAM ENDOCULAR PROBE?

MEGABEAM ENDOCULAR PROBE is a medical device that received FDA 510(k) clearance on 1994-04-01. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K935747.

When did MEGABEAM ENDOCULAR PROBE receive FDA 510(k) clearance?

MEGABEAM ENDOCULAR PROBE received FDA 510(k) clearance on 1994-04-01, under 510(k) number K935747.

Who is the listed applicant for MEGABEAM ENDOCULAR PROBE?

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

What is the FDA product code for MEGABEAM ENDOCULAR PROBE?

The FDA product code for MEGABEAM ENDOCULAR PROBE is HQF.

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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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