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FDA 510(k)

EPILASER I UPGRADE KIT

K-Number: K980160 · 1998-03-10

ApplicantPalomar Medical Products, Inc.
Decision Date1998-03-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPILASER I UPGRADE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Palomar Medical Products, Inc.. It received FDA 510(k) clearance on 1998-03-10 under 510(k) number K980160. 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 EPILASER I UPGRADE KIT?

EPILASER I UPGRADE KIT is a medical device that received FDA 510(k) clearance on 1998-03-10. The listed applicant is Palomar Medical Products, Inc.. The 510(k) number is K980160.

When did EPILASER I UPGRADE KIT receive FDA 510(k) clearance?

EPILASER I UPGRADE KIT received FDA 510(k) clearance on 1998-03-10, under 510(k) number K980160.

Who is the listed applicant for EPILASER I UPGRADE KIT?

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

What is the FDA product code for EPILASER I UPGRADE KIT?

The FDA product code for EPILASER I UPGRADE KIT 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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