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FDA 510(k)

AHWON'S IPL SYSTEM

K-Number: K102857 · 2011-01-14

Decision Date2011-01-14
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AHWON'S IPL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ahwon Medi Instrument Co., Ltd.. It received FDA 510(k) clearance on 2011-01-14 under 510(k) number K102857. 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 AHWON'S IPL SYSTEM?

AHWON'S IPL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-14. The listed applicant is Ahwon Medi Instrument Co., Ltd.. The 510(k) number is K102857.

When did AHWON'S IPL SYSTEM receive FDA 510(k) clearance?

AHWON'S IPL SYSTEM received FDA 510(k) clearance on 2011-01-14, under 510(k) number K102857.

Who is the listed applicant for AHWON'S IPL SYSTEM?

The FDA 510(k) record lists Ahwon Medi Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AHWON'S IPL SYSTEM?

The FDA product code for AHWON'S IPL SYSTEM is ONF.

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.

Related Devices (Code: ONF)

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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