Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Cyden Limited. It received FDA 510(k) clearance on 2023-12-20 under approval 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. It is manufactured by Cyden Limited. The 510(k) number is K233782.

When was SmoothSkin Pure Adapt (SSG3) approved by the FDA?

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

What company makes SmoothSkin Pure Adapt (SSG3)?

SmoothSkin Pure Adapt (SSG3) is manufactured by Cyden Limited.

What is the FDA product code for SmoothSkin Pure Adapt (SSG3)?

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

Other Devices by Cyden Limited

View all 14 devices →

Related Devices (Code: OHT)

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.