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FDA 510(k)

MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG

K-Number: K900630 · 1990-05-04

ApplicantHeraeus Lasersonics, Inc.
Decision Date1990-05-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG 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 1990-05-04 under 510(k) number K900630. 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 MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG?

MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG is a medical device that received FDA 510(k) clearance on 1990-05-04. The listed applicant is Heraeus Lasersonics, Inc.. The 510(k) number is K900630.

When did MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG receive FDA 510(k) clearance?

MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG received FDA 510(k) clearance on 1990-05-04, under 510(k) number K900630.

Who is the listed applicant for MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG?

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 MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG?

The FDA product code for MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG 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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