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FDA 510(k)

KTP/532 & KTP/YAG SURGICAL LASERS

K-Number: K913244 · 1992-07-28

ApplicantCharles L. Rose and Co., Inc.
Decision Date1992-07-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KTP/532 & KTP/YAG SURGICAL LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Charles L. Rose and Co., Inc.. It received FDA 510(k) clearance on 1992-07-28 under 510(k) number K913244. 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 SURGICAL LASERS?

KTP/532 & KTP/YAG SURGICAL LASERS is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Charles L. Rose and Co., Inc.. The 510(k) number is K913244.

When did KTP/532 & KTP/YAG SURGICAL LASERS receive FDA 510(k) clearance?

KTP/532 & KTP/YAG SURGICAL LASERS received FDA 510(k) clearance on 1992-07-28, under 510(k) number K913244.

Who is the listed applicant for KTP/532 & KTP/YAG SURGICAL LASERS?

The FDA 510(k) record lists Charles L. Rose and Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KTP/532 & KTP/YAG SURGICAL LASERS?

The FDA product code for KTP/532 & KTP/YAG SURGICAL LASERS is GEX. This falls under the Gastroenterology category.

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Other records listing Charles L. Rose and Co., Inc. as applicant

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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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