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FDA 510(k)

4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER

K-Number: K881619 · 1988-07-08

ApplicantHeraeus Lasersonics, Inc.
Decision Date1988-07-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER 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 1988-07-08 under 510(k) number K881619. 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 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER?

4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Heraeus Lasersonics, Inc.. The 510(k) number is K881619.

When did 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER receive FDA 510(k) clearance?

4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER received FDA 510(k) clearance on 1988-07-08, under 510(k) number K881619.

Who is the listed applicant for 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER?

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 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER?

The FDA product code for 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER 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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