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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 a medical device manufactured by Li-Tek Electronics Technologies. It received FDA 510(k) clearance on 2017-09-28 under approval 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. It is manufactured by Li-Tek Electronics Technologies. The 510(k) number is K161434.

When was Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) approved by the FDA?

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

What company makes Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)?

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is manufactured by Li-Tek Electronics Technologies.

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.

Related Clinical Trials

NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07613814 Development of a Management Model for Hyperemesis in Pregnant Women Through the "Vibratory Emesis Massage" COMPLETED NCT07611643 Bruxism Therapy of Facial Pain RECRUITING NCT07343141 To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds NOT_YET_RECRUITING NCT06291818 Self-Adhering Magnetic Device to Treat Corneal Exposure RECRUITING

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41672626 [Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

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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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