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FDA 510(k)

IPULSE HAIR REMOVAL SYSTEM

K-Number: K130315 · 2013-07-12

ApplicantCyden Limited
Decision Date2013-07-12
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPULSE HAIR REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2013-07-12 under 510(k) number K130315. 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 HAIR REMOVAL SYSTEM?

IPULSE HAIR REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 2013-07-12. The listed applicant is Cyden Limited. The 510(k) number is K130315.

When did IPULSE HAIR REMOVAL SYSTEM receive FDA 510(k) clearance?

IPULSE HAIR REMOVAL SYSTEM received FDA 510(k) clearance on 2013-07-12, under 510(k) number K130315.

Who is the listed applicant for IPULSE HAIR REMOVAL SYSTEM?

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 HAIR REMOVAL SYSTEM?

The FDA product code for IPULSE HAIR REMOVAL SYSTEM is OHT.

Related Clinical Trials

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.

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 22 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

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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