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FDA 510(k)

OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO

K-Number: K862514 · 1987-02-04

ApplicantLaserscope
Decision Date1987-02-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1987-02-04 under 510(k) number K862514. 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 OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO?

OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Laserscope. The 510(k) number is K862514.

When did OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO receive FDA 510(k) clearance?

OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO received FDA 510(k) clearance on 1987-02-04, under 510(k) number K862514.

Who is the listed applicant for OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO?

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

What is the FDA product code for OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO?

The FDA product code for OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO is GEX. This falls under the Gastroenterology category.

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Other records listing Laserscope as applicant

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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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