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FDA 510(k)

MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS

K-Number: K980685 · 1998-05-20

ApplicantLumenis, Inc.
Decision Date1998-05-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K980685. 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 MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS?

MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Lumenis, Inc.. The 510(k) number is K980685.

When did MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS receive FDA 510(k) clearance?

MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS received FDA 510(k) clearance on 1998-05-20, under 510(k) number K980685.

Who is the listed applicant for MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS?

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

What is the FDA product code for MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS?

The FDA product code for MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis, Inc. 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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