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FDA 510(k)

HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE

K-Number: K913564 · 1991-09-16

ApplicantHeraeus Lasersonics, Inc.
Decision Date1991-09-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE 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 1991-09-16 under 510(k) number K913564. 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 HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE?

HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE is a medical device that received FDA 510(k) clearance on 1991-09-16. The listed applicant is Heraeus Lasersonics, Inc.. The 510(k) number is K913564.

When did HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE receive FDA 510(k) clearance?

HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE received FDA 510(k) clearance on 1991-09-16, under 510(k) number K913564.

Who is the listed applicant for HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE?

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 HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE?

The FDA product code for HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE 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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