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FDA 510(k)

LASIK EYE DRAPE

K-Number: K042977 · 2005-05-10

ApplicantOdyssey Medical, Inc.
Decision Date2005-05-10
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASIK EYE DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Odyssey Medical, Inc.. It received FDA 510(k) clearance on 2005-05-10 under 510(k) number K042977. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASIK EYE DRAPE?

LASIK EYE DRAPE is a medical device that received FDA 510(k) clearance on 2005-05-10. The listed applicant is Odyssey Medical, Inc.. The 510(k) number is K042977.

When did LASIK EYE DRAPE receive FDA 510(k) clearance?

LASIK EYE DRAPE received FDA 510(k) clearance on 2005-05-10, under 510(k) number K042977.

Who is the listed applicant for LASIK EYE DRAPE?

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

What is the FDA product code for LASIK EYE DRAPE?

The FDA product code for LASIK EYE DRAPE is KKX.

Related Clinical Trials

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Other records listing Odyssey Medical, 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.

K090938FLOW CONTROLLERK972523PUNCTUAL OCCLUDERK970631PUNCTUAL OCCLUDER

Related Devices (Code: KKX)

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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