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FDA 510(k)

UltraLight LED System

K-Number: K210535 · 2021-05-24

ApplicantRohrer Aesthetics, LLC
Decision Date2021-05-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UltraLight LED System is the device name listed in this FDA 510(k) record. The listed applicant is Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2021-05-24 under 510(k) number K210535. 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 UltraLight LED System?

UltraLight LED System is a medical device that received FDA 510(k) clearance on 2021-05-24. The listed applicant is Rohrer Aesthetics, LLC. The 510(k) number is K210535.

When did UltraLight LED System receive FDA 510(k) clearance?

UltraLight LED System received FDA 510(k) clearance on 2021-05-24, under 510(k) number K210535.

Who is the listed applicant for UltraLight LED System?

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

What is the FDA product code for UltraLight LED System?

The FDA product code for UltraLight LED System 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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