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FDA 510(k)

IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650

K-Number: K093627 · 2011-01-18

ApplicantShanghai Apolo Medical Technologies Co., Ltd.
Decision Date2011-01-18
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2011-01-18 under 510(k) number K093627. 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 IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650?

IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 is a medical device that received FDA 510(k) clearance on 2011-01-18. The listed applicant is Shanghai Apolo Medical Technologies Co., Ltd.. The 510(k) number is K093627.

When did IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 receive FDA 510(k) clearance?

IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 received FDA 510(k) clearance on 2011-01-18, under 510(k) number K093627.

Who is the listed applicant for IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650?

The FDA 510(k) record lists Shanghai Apolo Medical Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650?

The FDA product code for IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 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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