Decision Date2017-03-23
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PerfectSmooth is the device name listed in this FDA 510(k) record. The listed applicant is Shen Zhen Cosbeauty Co., Ltd.. It received FDA 510(k) clearance on 2017-03-23 under 510(k) number K161428. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PerfectSmooth?
PerfectSmooth is a medical device that received FDA 510(k) clearance on 2017-03-23. The listed applicant is Shen Zhen Cosbeauty Co., Ltd.. The 510(k) number is K161428.
When did PerfectSmooth receive FDA 510(k) clearance?
PerfectSmooth received FDA 510(k) clearance on 2017-03-23, under 510(k) number K161428.
Who is the listed applicant for PerfectSmooth?
The FDA 510(k) record lists Shen Zhen Cosbeauty Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PerfectSmooth?
The FDA product code for PerfectSmooth is OHT.
Other records listing Shen Zhen Cosbeauty Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: OHT)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.