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FDA 510(k)

LUXUS 132 ND: YAG SURGICAL LASER SYSTEM

K-Number: K911987 · 1991-08-13

ApplicantHeraeus Lasersonics, Inc.
Decision Date1991-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUXUS 132 ND: YAG SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Lasersonics, Inc.. It received FDA 510(k) clearance on 1991-08-13 under 510(k) number K911987. 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 LUXUS 132 ND: YAG SURGICAL LASER SYSTEM?

LUXUS 132 ND: YAG SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-08-13. The listed applicant is Heraeus Lasersonics, Inc.. The 510(k) number is K911987.

When did LUXUS 132 ND: YAG SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

LUXUS 132 ND: YAG SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1991-08-13, under 510(k) number K911987.

Who is the listed applicant for LUXUS 132 ND: YAG SURGICAL LASER SYSTEM?

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

What is the FDA product code for LUXUS 132 ND: YAG SURGICAL LASER SYSTEM?

The FDA product code for LUXUS 132 ND: YAG SURGICAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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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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