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FDA 510(k)

LASERSCOPE AUTOMATIC EYE PROTECTION FILTER

K-Number: K970157 · 1997-04-07

ApplicantLaserscope
Decision Date1997-04-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERSCOPE AUTOMATIC EYE PROTECTION FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1997-04-07 under 510(k) number K970157. 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 LASERSCOPE AUTOMATIC EYE PROTECTION FILTER?

LASERSCOPE AUTOMATIC EYE PROTECTION FILTER is a medical device that received FDA 510(k) clearance on 1997-04-07. The listed applicant is Laserscope. The 510(k) number is K970157.

When did LASERSCOPE AUTOMATIC EYE PROTECTION FILTER receive FDA 510(k) clearance?

LASERSCOPE AUTOMATIC EYE PROTECTION FILTER received FDA 510(k) clearance on 1997-04-07, under 510(k) number K970157.

Who is the listed applicant for LASERSCOPE AUTOMATIC EYE PROTECTION FILTER?

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

What is the FDA product code for LASERSCOPE AUTOMATIC EYE PROTECTION FILTER?

The FDA product code for LASERSCOPE AUTOMATIC EYE PROTECTION FILTER is GEX. This falls under the Gastroenterology category.

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Other records listing Laserscope 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.

K062719GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIESK061646LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIESK034011GEMINI SURGICAL LASER SYSTEM & ACCESSORIESK024206AURA ISURGICAL LASER SYSTEM & ACCESSORIESK020021LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)K010834LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES

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Related Devices (Code: GEX)

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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