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FDA 510(k)

LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY

K-Number: K912618 · 1992-02-27

ApplicantHeraeus Lasersonics, Inc.
Decision Date1992-02-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY 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 1992-02-27 under 510(k) number K912618. 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 LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY?

LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY is a medical device that received FDA 510(k) clearance on 1992-02-27. The listed applicant is Heraeus Lasersonics, Inc.. The 510(k) number is K912618.

When did LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY receive FDA 510(k) clearance?

LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY received FDA 510(k) clearance on 1992-02-27, under 510(k) number K912618.

Who is the listed applicant for LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY?

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 LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY?

The FDA product code for LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY is GEX. This falls under the Gastroenterology category.

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Related Devices (Code: GEX)

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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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