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FDA 510(k)

IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)

K-Number: K243085 · 2024-12-21

ApplicantZhuzhou Goldenhot Medical Technology Co., Ltd.
Decision Date2024-12-21
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) is a medical device manufactured by Zhuzhou Goldenhot Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-21 under approval number K243085. 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 Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)?

IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) is a medical device that received FDA 510(k) clearance on 2024-12-21. It is manufactured by Zhuzhou Goldenhot Medical Technology Co., Ltd.. The 510(k) number is K243085.

When was IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) approved by the FDA?

IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) received FDA 510(k) clearance on 2024-12-21, under approval number K243085.

What company makes IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)?

IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) is manufactured by Zhuzhou Goldenhot Medical Technology Co., Ltd..

What is the FDA product code for IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)?

The FDA product code for IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) is OHT.

Related Clinical Trials

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Other Devices by Zhuzhou Goldenhot Medical Technology Co., Ltd.

K231613Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. K240109Medical electronic thermometer (FC01, FC02)

Related Devices (Code: OHT)

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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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