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FDA 510(k)

ESPADA Acne-Clearing Blue Light Pen

K-Number: K162450 · 2016-11-30

ApplicantForeo, Inc.
Decision Date2016-11-30
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESPADA Acne-Clearing Blue Light Pen is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K162450. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESPADA Acne-Clearing Blue Light Pen?

ESPADA Acne-Clearing Blue Light Pen is a medical device that received FDA 510(k) clearance on 2016-11-30. The listed applicant is Foreo, Inc.. The 510(k) number is K162450.

When did ESPADA Acne-Clearing Blue Light Pen receive FDA 510(k) clearance?

ESPADA Acne-Clearing Blue Light Pen received FDA 510(k) clearance on 2016-11-30, under 510(k) number K162450.

Who is the listed applicant for ESPADA Acne-Clearing Blue Light Pen?

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

What is the FDA product code for ESPADA Acne-Clearing Blue Light Pen?

The FDA product code for ESPADA Acne-Clearing Blue Light Pen is OLP.

Other records listing Foreo, Inc. 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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