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510(k) Data Aggregation
K Number
K250183Device Name
CO2 Laser System (CO2 Laser SST-L23)
Manufacturer
Date Cleared
2025-04-24
(92 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Zhuozhou Summer Star Technologies Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Device Description
CO2 Laser System is a laser beam generated by electrically excited carbon dioxide gas molecules, which has a very small divergence angle and high energy density. After focusing, it can reach a power of several kilowatts per square centimeter for vaporization. The unfocused original light beam irradiates the lesion tissue, which can cause coagulation of biological tissue. The CO2 laser penetrates the tissue deeper, and after irradiation, it can heat and treat the deep tissue.
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