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FDA 510(k)

POLYLASE LP

K-Number: K040055 · 2004-04-07

ApplicantDdc Technologies, Inc.
Decision Date2004-04-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLYLASE LP is the device name listed in this FDA 510(k) record. The listed applicant is Ddc Technologies, Inc.. It received FDA 510(k) clearance on 2004-04-07 under 510(k) number K040055. 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 POLYLASE LP?

POLYLASE LP is a medical device that received FDA 510(k) clearance on 2004-04-07. The listed applicant is Ddc Technologies, Inc.. The 510(k) number is K040055.

When did POLYLASE LP receive FDA 510(k) clearance?

POLYLASE LP received FDA 510(k) clearance on 2004-04-07, under 510(k) number K040055.

Who is the listed applicant for POLYLASE LP?

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

What is the FDA product code for POLYLASE LP?

The FDA product code for POLYLASE LP is GEX. This falls under the Gastroenterology category.

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Other records listing Ddc Technologies, Inc. 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.

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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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