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FDA 510(k)

AURA LASER SYSTEM

K-Number: K951034 · 1995-04-13

ApplicantLaserscope
Decision Date1995-04-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AURA LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1995-04-13 under 510(k) number K951034. 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 AURA LASER SYSTEM?

AURA LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-13. The listed applicant is Laserscope. The 510(k) number is K951034.

When did AURA LASER SYSTEM receive FDA 510(k) clearance?

AURA LASER SYSTEM received FDA 510(k) clearance on 1995-04-13, under 510(k) number K951034.

Who is the listed applicant for AURA LASER SYSTEM?

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 AURA LASER SYSTEM?

The FDA product code for AURA LASER SYSTEM 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)

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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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