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FDA 510(k)

SmoothSkin Pure Adapt (SSG3)

K-Number: K233782 · 2023-12-20

ApplicantCyden Limited
Decision Date2023-12-20
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SmoothSkin Pure Adapt (SSG3) is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K233782. 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 Adapt (SSG3)?

SmoothSkin Pure Adapt (SSG3) is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Cyden Limited. The 510(k) number is K233782.

When did SmoothSkin Pure Adapt (SSG3) receive FDA 510(k) clearance?

SmoothSkin Pure Adapt (SSG3) received FDA 510(k) clearance on 2023-12-20, under 510(k) number K233782.

Who is the listed applicant for SmoothSkin Pure Adapt (SSG3)?

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 Adapt (SSG3)?

The FDA product code for SmoothSkin Pure Adapt (SSG3) 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.

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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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