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FDA 510(k)

Aduro light therapy Handheld

K-Number: K203271 · 2021-07-21

ApplicantShenzhen Kaiyan Medical CO , Ltd.
Decision Date2021-07-21
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aduro light therapy Handheld is a medical device manufactured by Shenzhen Kaiyan Medical CO , Ltd.. It received FDA 510(k) clearance on 2021-07-21 under approval number K203271. 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 Aduro light therapy Handheld?

Aduro light therapy Handheld is a medical device that received FDA 510(k) clearance on 2021-07-21. It is manufactured by Shenzhen Kaiyan Medical CO , Ltd.. The 510(k) number is K203271.

When was Aduro light therapy Handheld approved by the FDA?

Aduro light therapy Handheld received FDA 510(k) clearance on 2021-07-21, under approval number K203271.

What company makes Aduro light therapy Handheld?

Aduro light therapy Handheld is manufactured by Shenzhen Kaiyan Medical CO , Ltd..

What is the FDA product code for Aduro light therapy Handheld?

The FDA product code for Aduro light therapy Handheld is OLP.

Related Clinical Trials

NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07610967 Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections NOT_YET_RECRUITING NCT05738239 Photo-biomodulation Therapy for Pain Relief After Caesarean Section COMPLETED NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07600957 Polarized Light Therapy for Radiation Dermatitis in Breast Cancer RECRUITING

Related PubMed Literature

PMID: 29060903 Development of evaluation methods for the approval and review of Intense pulsed light (IPL). Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2017)

Other Devices by Shenzhen Kaiyan Medical CO , Ltd.

K213024Oren LED Perioral Light Therapy System K203214DemarkQ WOW, DemarkQ POP K202390Aduro Light Beauty Mask K220168Skin Care Beauty Mask (Model: MJ-06)

Related Devices (Code: OLP)

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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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