FDA 510(k)

HI-EMT MAGSHAPE

K-Number: K230024 · 2023-09-06

ApplicantBeijing Sano Laser S&T Development Co.,Ltd

Decision Date2023-09-06

Product CodeNGX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

HI-EMT MAGSHAPE is a medical device manufactured by Beijing Sano Laser S&T Development Co.,Ltd. It received FDA 510(k) clearance on 2023-09-06 under approval number K230024. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI-EMT MAGSHAPE?

HI-EMT MAGSHAPE is a medical device that received FDA 510(k) clearance on 2023-09-06. It is manufactured by Beijing Sano Laser S&T Development Co.,Ltd. The 510(k) number is K230024.

When was HI-EMT MAGSHAPE approved by the FDA?

HI-EMT MAGSHAPE received FDA 510(k) clearance on 2023-09-06, under approval number K230024.

What company makes HI-EMT MAGSHAPE?

HI-EMT MAGSHAPE is manufactured by Beijing Sano Laser S&T Development Co.,Ltd.

What is the FDA product code for HI-EMT MAGSHAPE?

The FDA product code for HI-EMT MAGSHAPE is NGX.

Other Devices by Beijing Sano Laser S&T Development Co.,Ltd

K191970Diode Laser Hair Removal System K233416Cryojet Plus (SHE-ACP001-1) K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1) K242941CO2 Laser Therapy Systems (SHE-LSP003-1)

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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.