Class Class II

Diode laser system (Night Universe; Predator) (K250206)

K250206 2025-04-24 Traditional
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Description

Diode laser system (Night Universe; Predator) by Ivylaser (Beijing) Technology Co.,Ltd, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250206
Clearance Date2025-04-24
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810

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Predicate lineage for K250206

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. Diode laser system (Night Universe; Predator) (K250206) 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
K222064The Alma Soprano TitaniumAlma Lasers, Inc.2022

Trace the full predicate network for K250206

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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