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FDA 510(k)

Home use hair removal device

K-Number: K220248 · 2022-07-01

ApplicantShenzhen Mareal Tech Co., Ltd.
Decision Date2022-07-01
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Home use hair removal device is a medical device manufactured by Shenzhen Mareal Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under approval number K220248. 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 Home use hair removal device?

Home use hair removal device is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Shenzhen Mareal Tech Co., Ltd.. The 510(k) number is K220248.

When was Home use hair removal device approved by the FDA?

Home use hair removal device received FDA 510(k) clearance on 2022-07-01, under approval number K220248.

What company makes Home use hair removal device?

Home use hair removal device is manufactured by Shenzhen Mareal Tech Co., Ltd..

What is the FDA product code for Home use hair removal device?

The FDA product code for Home use hair removal device is OHT.

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Other Devices by Shenzhen Mareal Tech Co., Ltd.

K172883Home Use Hair Removal Device/T1, T2, T3

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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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