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FDA 510(k)

BRAUN Silk Expert Pro 3

K-Number: K190366 · 2019-03-18

ApplicantCyden Limited
Decision Date2019-03-18
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BRAUN Silk Expert Pro 3 is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2019-03-18 under 510(k) number K190366. 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 BRAUN Silk Expert Pro 3?

BRAUN Silk Expert Pro 3 is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is Cyden Limited. The 510(k) number is K190366.

When did BRAUN Silk Expert Pro 3 receive FDA 510(k) clearance?

BRAUN Silk Expert Pro 3 received FDA 510(k) clearance on 2019-03-18, under 510(k) number K190366.

Who is the listed applicant for BRAUN Silk Expert Pro 3?

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 BRAUN Silk Expert Pro 3?

The FDA product code for BRAUN Silk Expert Pro 3 is OHT.

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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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