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FDA 510(k)

KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II

K-Number: K980398 · 1998-09-22

ApplicantOptomedic Medical Technologies , Ltd.
Decision Date1998-09-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II is the device name listed in this FDA 510(k) record. The listed applicant is Optomedic Medical Technologies , Ltd.. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K980398. 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 KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II?

KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Optomedic Medical Technologies , Ltd.. The 510(k) number is K980398.

When did KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II receive FDA 510(k) clearance?

KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II received FDA 510(k) clearance on 1998-09-22, under 510(k) number K980398.

Who is the listed applicant for KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II?

The FDA 510(k) record lists Optomedic Medical Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II?

The FDA product code for KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II is GEX. This falls under the Gastroenterology category.

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Other records listing Optomedic Medical Technologies , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950313KAPLAN PENDULASER 115 - A 15W CO2 SURGICAL LASER

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Official Source

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