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FDA 510(k)

Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K

K-Number: K223928 · 2023-03-28

ApplicantShenzhen Fansizhe Science and Technology Co., Ltd.
Decision Date2023-03-28
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K is a medical device manufactured by Shenzhen Fansizhe Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-28 under approval number K223928. 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 Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K?

Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K is a medical device that received FDA 510(k) clearance on 2023-03-28. It is manufactured by Shenzhen Fansizhe Science and Technology Co., Ltd.. The 510(k) number is K223928.

When was Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K approved by the FDA?

Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K received FDA 510(k) clearance on 2023-03-28, under approval number K223928.

What company makes Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K?

Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K is manufactured by Shenzhen Fansizhe Science and Technology Co., Ltd..

What is the FDA product code for Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K?

The FDA product code for Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K is OHT.

Related Clinical Trials

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Other Devices by Shenzhen Fansizhe Science and Technology Co., Ltd.

K221569Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K K212881Intense Pulsed Light (IPL) System K253881Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) K251173Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)

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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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