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FDA 510(k)

SmoothSkin Pure Mini

K-Number: K213692 · 2022-01-26

ApplicantCyden Limited
Decision Date2022-01-26
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SmoothSkin Pure Mini is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K213692. 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 SmoothSkin Pure Mini?

SmoothSkin Pure Mini is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Cyden Limited. The 510(k) number is K213692.

When did SmoothSkin Pure Mini receive FDA 510(k) clearance?

SmoothSkin Pure Mini received FDA 510(k) clearance on 2022-01-26, under 510(k) number K213692.

Who is the listed applicant for SmoothSkin Pure Mini?

The FDA 510(k) record lists Cyden Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmoothSkin Pure Mini?

The FDA product code for SmoothSkin Pure Mini is OHT.

Other records listing Cyden Limited 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.

K243362SmoothSkin Pure Switch (SSC1)K240587SmoothSkin Pure Unplugged (SSB3)K233782SmoothSkin Pure Adapt (SSG3)K230911Braun Skin i.expertK211994Braun Silk.expert MiniK200184SmoothSkin Pure

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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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