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FDA 510(k)

RED Light Device

K-Number: K162489 · 2017-01-13

ApplicantZhongshan Bisen Plastic Electronic Products Co., Ltd.
Decision Date2017-01-13
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RED Light Device is a medical device manufactured by Zhongshan Bisen Plastic Electronic Products Co., Ltd.. It received FDA 510(k) clearance on 2017-01-13 under approval number K162489. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RED Light Device?

RED Light Device is a medical device that received FDA 510(k) clearance on 2017-01-13. It is manufactured by Zhongshan Bisen Plastic Electronic Products Co., Ltd.. The 510(k) number is K162489.

When was RED Light Device approved by the FDA?

RED Light Device received FDA 510(k) clearance on 2017-01-13, under approval number K162489.

What company makes RED Light Device?

RED Light Device is manufactured by Zhongshan Bisen Plastic Electronic Products Co., Ltd..

What is the FDA product code for RED Light Device?

The FDA product code for RED Light Device is OHS.

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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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