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FDA 510(k)

MMD Tip

K-Number: K181480 · 2018-08-01

ApplicantStrata Skin Sciences, Inc.
Decision Date2018-08-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MMD Tip is the device name listed in this FDA 510(k) record. The listed applicant is Strata Skin Sciences, Inc.. It received FDA 510(k) clearance on 2018-08-01 under 510(k) number K181480. 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 MMD Tip?

MMD Tip is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Strata Skin Sciences, Inc.. The 510(k) number is K181480.

When did MMD Tip receive FDA 510(k) clearance?

MMD Tip received FDA 510(k) clearance on 2018-08-01, under 510(k) number K181480.

Who is the listed applicant for MMD Tip?

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

What is the FDA product code for MMD Tip?

The FDA product code for MMD Tip is GEX. This falls under the Gastroenterology category.

Other records listing Strata Skin Sciences, Inc. as applicant

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Related Devices (Code: GEX)

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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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