Class Class II
Diode laser device (BM091) (K251801)
Description
Diode laser device (BM091) by Hebei Newangie Technology Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251801
Clearance Date2025-08-08
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251801
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 device (BM091) (K251801) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241642 | Diode Laser Hair Removal System (MBT-Diode Laser) | Beijing Mega Beauty Technology Co.,... | 2024 |
| K232709 | Diode laser therapy device | Hebei Zhemai Technology Co., Ltd. | 2023 |
Trace the full predicate network for K251801
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.