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FDA 510(k)

KTP/532, KTP/YAG AND KTP/YAG XP

K-Number: K931445 · 1994-12-02

ApplicantLaser Surgical Systems
Decision Date1994-12-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KTP/532, KTP/YAG AND KTP/YAG XP is the device name listed in this FDA 510(k) record. The listed applicant is Laser Surgical Systems. It received FDA 510(k) clearance on 1994-12-02 under 510(k) number K931445. 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 KTP/532, KTP/YAG AND KTP/YAG XP?

KTP/532, KTP/YAG AND KTP/YAG XP is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is Laser Surgical Systems. The 510(k) number is K931445.

When did KTP/532, KTP/YAG AND KTP/YAG XP receive FDA 510(k) clearance?

KTP/532, KTP/YAG AND KTP/YAG XP received FDA 510(k) clearance on 1994-12-02, under 510(k) number K931445.

Who is the listed applicant for KTP/532, KTP/YAG AND KTP/YAG XP?

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

What is the FDA product code for KTP/532, KTP/YAG AND KTP/YAG XP?

The FDA product code for KTP/532, KTP/YAG AND KTP/YAG XP is GEX. This falls under the Gastroenterology category.

Other records listing Laser Surgical Systems 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.

K925266SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODESK922807FIBERLIFE

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

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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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