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FDA 510(k)

IPL Cooling Hair Removal Device

K-Number: K232845 · 2023-11-14

ApplicantShenzhen Siken 3D Technology Development Co., Ltd.
Decision Date2023-11-14
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Cooling Hair Removal Device is a medical device manufactured by Shenzhen Siken 3D Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2023-11-14 under approval number K232845. 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 IPL Cooling Hair Removal Device?

IPL Cooling Hair Removal Device is a medical device that received FDA 510(k) clearance on 2023-11-14. It is manufactured by Shenzhen Siken 3D Technology Development Co., Ltd.. The 510(k) number is K232845.

When was IPL Cooling Hair Removal Device approved by the FDA?

IPL Cooling Hair Removal Device received FDA 510(k) clearance on 2023-11-14, under approval number K232845.

What company makes IPL Cooling Hair Removal Device?

IPL Cooling Hair Removal Device is manufactured by Shenzhen Siken 3D Technology Development Co., Ltd..

What is the FDA product code for IPL Cooling Hair Removal Device?

The FDA product code for IPL Cooling Hair Removal Device is OHT.

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Other Devices by Shenzhen Siken 3D Technology Development Co., Ltd.

K163470Galvanic Spa, Model: SKB-1405 K222710IPL Cooling Hair Removal Device K243040LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

Related Devices (Code: OHT)

K162231iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expertCyden Limited K161089sensiLight MiniEl Global Trade, Ltd. K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited K172181micro IPLEl Global Trade, Ltd. K171433Silk'n InfinityHome Skinovations , Ltd. K170269Hee HR MiniOriental Inspiration Limited

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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