Class Class II

SurgiLight 1470 Diode Laser System (Model:Halo) (K251049)

K251049 2025-07-02 Traditional
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Description

SurgiLight 1470 Diode Laser System (Model:Halo) by Micro-Energy Medical Technology Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251049
Clearance Date2025-07-02
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810

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Predicate lineage for K251049

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. SurgiLight 1470 Diode Laser System (Model:Halo) (K251049) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.2024
K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser , Ltd.2015

Trace the full predicate network for K251049

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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