Class Class II
CO2 Laser Machine (Lume) (K250465)
Description
CO2 Laser Machine (Lume) by Nanjing Bestview Laser S&T Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250465
Clearance Date2025-06-09
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250465
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. CO2 Laser Machine (Lume) (K250465) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201109 | CO2 Laser Therapy System | Shanghai Apolo Medical Technology C... | 2020 |
| K162169 | EdgeOne CO2 Laser | Jeisys Medical, Inc. | 2016 |
Trace the full predicate network for K250465
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.