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FDA 510(k)

CO2 Laser Therapy Systems (SHE-LSP003-1)

K-Number: K242941 · 2025-01-27

ApplicantBeijing Sano Laser S&T Development Co.,Ltd
Decision Date2025-01-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CO2 Laser Therapy Systems (SHE-LSP003-1) is a medical device manufactured by Beijing Sano Laser S&T Development Co.,Ltd. It received FDA 510(k) clearance on 2025-01-27 under approval number K242941. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO2 Laser Therapy Systems (SHE-LSP003-1)?

CO2 Laser Therapy Systems (SHE-LSP003-1) is a medical device that received FDA 510(k) clearance on 2025-01-27. It is manufactured by Beijing Sano Laser S&T Development Co.,Ltd. The 510(k) number is K242941.

When was CO2 Laser Therapy Systems (SHE-LSP003-1) approved by the FDA?

CO2 Laser Therapy Systems (SHE-LSP003-1) received FDA 510(k) clearance on 2025-01-27, under approval number K242941.

What company makes CO2 Laser Therapy Systems (SHE-LSP003-1)?

CO2 Laser Therapy Systems (SHE-LSP003-1) is manufactured by Beijing Sano Laser S&T Development Co.,Ltd.

What is the FDA product code for CO2 Laser Therapy Systems (SHE-LSP003-1)?

The FDA product code for CO2 Laser Therapy Systems (SHE-LSP003-1) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Related PubMed Literature

PMID: 41483832 Emerging nanodelivery systems for cuproptosis induction: design strategies and multidimensional regulatory mechanisms. International journal of pharmaceutics (2026) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

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

K191970Diode Laser Hair Removal System K230024HI-EMT MAGSHAPE K233416Cryojet Plus (SHE-ACP001-1) K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)

Related Devices (Code: GEX)

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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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