Class Class II
Diode laser therapy device (K212733)
Description
Diode laser therapy device by Beijing Star New Tech Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK212733
Clearance Date2023-06-06
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K212733
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 therapy device (K212733) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K081015 | CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 | Biolitec, Inc. | 2008 |
| K073063 | 15W CERALAS D 1470NM DIODE LASER | Biolitec, Inc. | 2008 |
Trace the full predicate network for K212733
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.