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FDA 510(k)

APOLLO MINI IPL SYSTEM

K-Number: K081219 · 2008-06-30

ApplicantSandstone Medical Technologies, LLC
Decision Date2008-06-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

APOLLO MINI IPL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sandstone Medical Technologies, LLC. It received FDA 510(k) clearance on 2008-06-30 under 510(k) number K081219. 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 APOLLO MINI IPL SYSTEM?

APOLLO MINI IPL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-30. The listed applicant is Sandstone Medical Technologies, LLC. The 510(k) number is K081219.

When did APOLLO MINI IPL SYSTEM receive FDA 510(k) clearance?

APOLLO MINI IPL SYSTEM received FDA 510(k) clearance on 2008-06-30, under 510(k) number K081219.

Who is the listed applicant for APOLLO MINI IPL SYSTEM?

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

What is the FDA product code for APOLLO MINI IPL SYSTEM?

The FDA product code for APOLLO MINI IPL SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Sandstone Medical Technologies, LLC as applicant

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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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