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FDA 510(k)

Intense Pulsed Light (IPL) System

K-Number: K212881 · 2022-04-11

ApplicantShenzhen Fansizhe Science and Technology Co., Ltd.
Decision Date2022-04-11
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulsed Light (IPL) System is a medical device manufactured by Shenzhen Fansizhe Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-11 under approval number K212881. 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?

Intense Pulsed Light (IPL) System is a medical device that received FDA 510(k) clearance on 2022-04-11. It is manufactured by Shenzhen Fansizhe Science and Technology Co., Ltd.. The 510(k) number is K212881.

When was Intense Pulsed Light (IPL) System approved by the FDA?

Intense Pulsed Light (IPL) System received FDA 510(k) clearance on 2022-04-11, under approval number K212881.

What company makes Intense Pulsed Light (IPL) System?

Intense Pulsed Light (IPL) System is manufactured by Shenzhen Fansizhe Science and Technology Co., Ltd..

What is the FDA product code for Intense Pulsed Light (IPL) System?

The FDA product code for Intense Pulsed Light (IPL) System is OHT.

Related Clinical Trials

NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT06578104 PULSED AF Post-Approval Study RECRUITING NCT06335082 A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF ENROLLING_BY_INVITATION

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

K221569Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K K223928Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K 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

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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