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FDA 510(k)

MED-GENESIS PATIENT LASER EYE SHIELD

K-Number: K934459 · 1994-02-22

ApplicantMed-Genesis, Inc.
Decision Date1994-02-22
Product CodeIWS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MED-GENESIS PATIENT LASER EYE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Med-Genesis, Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K934459. The device is classified under product code IWS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MED-GENESIS PATIENT LASER EYE SHIELD?

MED-GENESIS PATIENT LASER EYE SHIELD is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Med-Genesis, Inc.. The 510(k) number is K934459.

When did MED-GENESIS PATIENT LASER EYE SHIELD receive FDA 510(k) clearance?

MED-GENESIS PATIENT LASER EYE SHIELD received FDA 510(k) clearance on 1994-02-22, under 510(k) number K934459.

Who is the listed applicant for MED-GENESIS PATIENT LASER EYE SHIELD?

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

What is the FDA product code for MED-GENESIS PATIENT LASER EYE SHIELD?

The FDA product code for MED-GENESIS PATIENT LASER EYE SHIELD is IWS.

Related Clinical Trials

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Related Devices (Code: IWS)

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.

K945515COATED TUNGSTEN EYESHIELDMedtec, Inc.K940119ROYAL MARSDEN GOLD GRAIN GUNBest IndustriesK943011TUNGSTEN EYESHIELDMedtec, Inc.K934362NUCLEAR ASSOCIATES GLASSERSVictoreen, Inc.K920540RADIOLOGICAL PROTECTIVE EYE SHIELDBurkhart Roentgen Intl., Inc.

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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