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510(k) K161434

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) by Li-Tek Electronics Technologies — Product Code OLP

K161434 is an FDA 510(k) premarket notification submitted by Li-Tek Electronics Technologies for the device "Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)". The FDA issued a decision of Substantially Equivalent on Sep 28, 2017. The device falls under product code OLP (Over-The-Counter Powered Light Based Laser For Acne), a Class II device regulated under 21 CFR 878.4810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 28, 2017
Date Received
May 24, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Powered Light Based Laser For Acne
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type
510(k)

The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

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FDA data resources