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FDA 510(k)

LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES

K-Number: K010834 · 2001-05-21

ApplicantLaserscope
Decision Date2001-05-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 2001-05-21 under 510(k) number K010834. 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 LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES?

LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES is a medical device that received FDA 510(k) clearance on 2001-05-21. The listed applicant is Laserscope. The 510(k) number is K010834.

When did LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES receive FDA 510(k) clearance?

LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES received FDA 510(k) clearance on 2001-05-21, under 510(k) number K010834.

Who is the listed applicant for LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES?

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 LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES?

The FDA product code for LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES 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)K010284LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)

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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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