PerfectSmooth

FDA 510(k) clearance K161428 · decided 2017-03-23

Clearance details

K-number: K161428
Device name: PerfectSmooth
Applicant: Shen Zhen Cosbeauty Co., Ltd.
Decision: Substantially Equivalent
Date received: 2016-05-23
Decision date: 2017-03-23
Days to decision: 304 days
Clearance type: Traditional
Product code: OHT
Device class: 2
Regulation number: 878.4810
Medical specialty: General, Plastic Surgery
Advisory committee: General, Plastic Surgery
Location: Shenzhen, CN
Third-party review: No
Expedited review: No

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Recalls involving this device

No recalls on record reference this clearance.