Decision Date2016-07-29
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Bright is the device name listed in this FDA 510(k) record. The listed applicant is Tanda Beauty Canada, Inc.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K161849. 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 Bright?
Bright is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Tanda Beauty Canada, Inc.. The 510(k) number is K161849.
When did Bright receive FDA 510(k) clearance?
Bright received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161849.
Who is the listed applicant for Bright?
The FDA 510(k) record lists Tanda Beauty Canada, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bright?
The FDA product code for Bright is OHS.
Related Devices (Code: OHS)
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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.