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FDA 510(k)

LASER EYE GOGGLES

K-Number: K970361 · 1997-03-18

ApplicantStefanovsky & Assoc.
Decision Date1997-03-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER EYE GOGGLES is the device name listed in this FDA 510(k) record. The listed applicant is Stefanovsky & Assoc.. It received FDA 510(k) clearance on 1997-03-18 under 510(k) number K970361. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER EYE GOGGLES?

LASER EYE GOGGLES is a medical device that received FDA 510(k) clearance on 1997-03-18. The listed applicant is Stefanovsky & Assoc.. The 510(k) number is K970361.

When did LASER EYE GOGGLES receive FDA 510(k) clearance?

LASER EYE GOGGLES received FDA 510(k) clearance on 1997-03-18, under 510(k) number K970361.

Who is the listed applicant for LASER EYE GOGGLES?

The FDA 510(k) record lists Stefanovsky & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASER EYE GOGGLES?

The FDA product code for LASER EYE GOGGLES is GEX. This falls under the Gastroenterology category.

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Other records listing Stefanovsky & Assoc. 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.

K833679LASER PROTECTIVE EYESHIELDK833232LASER PROTECTIVE EYESHIELD

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Official Source

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