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FDA 510(k)

iPulse SmoothSkin BARE Hair Removal Device

K-Number: K163552 · 2017-03-03

ApplicantCyden Limited
Decision Date2017-03-03
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

iPulse SmoothSkin BARE Hair Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K163552. 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 iPulse SmoothSkin BARE Hair Removal Device?

iPulse SmoothSkin BARE Hair Removal Device is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Cyden Limited. The 510(k) number is K163552.

When did iPulse SmoothSkin BARE Hair Removal Device receive FDA 510(k) clearance?

iPulse SmoothSkin BARE Hair Removal Device received FDA 510(k) clearance on 2017-03-03, under 510(k) number K163552.

Who is the listed applicant for iPulse SmoothSkin BARE Hair Removal Device?

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 iPulse SmoothSkin BARE Hair Removal Device?

The FDA product code for iPulse SmoothSkin BARE Hair Removal Device 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.

View all 14 devices →

Related Devices (Code: OHT)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.