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FDA 510(k)

PARADERM -585M DERMATOLOGICAL LASER

K-Number: K941559 · 1994-11-03

ApplicantParadigm Lasers, Inc.
Decision Date1994-11-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PARADERM -585M DERMATOLOGICAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Lasers, Inc.. It received FDA 510(k) clearance on 1994-11-03 under 510(k) number K941559. 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 PARADERM -585M DERMATOLOGICAL LASER?

PARADERM -585M DERMATOLOGICAL LASER is a medical device that received FDA 510(k) clearance on 1994-11-03. The listed applicant is Paradigm Lasers, Inc.. The 510(k) number is K941559.

When did PARADERM -585M DERMATOLOGICAL LASER receive FDA 510(k) clearance?

PARADERM -585M DERMATOLOGICAL LASER received FDA 510(k) clearance on 1994-11-03, under 510(k) number K941559.

Who is the listed applicant for PARADERM -585M DERMATOLOGICAL LASER?

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

What is the FDA product code for PARADERM -585M DERMATOLOGICAL LASER?

The FDA product code for PARADERM -585M DERMATOLOGICAL LASER is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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