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FDA 510(k)

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)

K-Number: K161434 · 2017-09-28

ApplicantLi-Tek Electronics Technologies
Decision Date2017-09-28
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is the device name listed in this FDA 510(k) record. The listed applicant is Li-Tek Electronics Technologies. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K161434. 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 Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)?

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Li-Tek Electronics Technologies. The 510(k) number is K161434.

When did Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) receive FDA 510(k) clearance?

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) received FDA 510(k) clearance on 2017-09-28, under 510(k) number K161434.

Who is the listed applicant for Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)?

The FDA 510(k) record lists Li-Tek Electronics Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)?

The FDA product code for Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is OLP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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