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 a medical device manufactured by Foreo, Inc.. It received FDA 510(k) clearance on 2016-11-30 under approval 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. It is manufactured by Foreo, Inc.. The 510(k) number is K162450.
When was ESPADA Acne-Clearing Blue Light Pen approved by the FDA?
ESPADA Acne-Clearing Blue Light Pen received FDA 510(k) clearance on 2016-11-30, under approval number K162450.
What company makes ESPADA Acne-Clearing Blue Light Pen?
ESPADA Acne-Clearing Blue Light Pen is manufactured by Foreo, Inc..
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 Devices by Foreo, Inc.
Related Devices (Code: OLP)
K162371Pulsaderm ACE-All BlueNutra Luxe MD, LLC
K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC
K160691Acne Light Therapy WandZuko, Inc.
K160821Tria SapphireTria Beauty, Inc.
K153081Clear Bi-LightMichael Todd, LP
K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies
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.