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FDA 510(k)

IPL THERAPY SYSTEM

K-Number: K123435 · 2013-02-11

ApplicantBeijing Sincoheren S&T Development Co, Ltd.
Decision Date2013-02-11
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sincoheren S&T Development Co, Ltd.. It received FDA 510(k) clearance on 2013-02-11 under 510(k) number K123435. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPL THERAPY SYSTEM?

IPL THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-11. The listed applicant is Beijing Sincoheren S&T Development Co, Ltd.. The 510(k) number is K123435.

When did IPL THERAPY SYSTEM receive FDA 510(k) clearance?

IPL THERAPY SYSTEM received FDA 510(k) clearance on 2013-02-11, under 510(k) number K123435.

Who is the listed applicant for IPL THERAPY SYSTEM?

The FDA 510(k) record lists Beijing Sincoheren S&T Development Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL THERAPY SYSTEM?

The FDA product code for IPL THERAPY SYSTEM is ONF.

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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.

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