Class Class II

Fractional CO2 Laser Therapy System (EXFU CO2) (K242183)

K242183 2024-10-23 Traditional
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Description

Fractional CO2 Laser Therapy System (EXFU CO2) by Weifang Mingliang Electronics Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242183
Clearance Date2024-10-23
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810

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Predicate lineage for K242183

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Fractional CO2 Laser Therapy System (EXFU CO2) (K242183) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K172096FraxisIlooda Co,., Ltd.2017

Trace the full predicate network for K242183

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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