Class Class II
Diode Laser System model Dawn-S (K243037)
Description
Diode Laser System model Dawn-S by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243037
Clearance Date2024-12-26
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243037
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 model Dawn-S (K243037) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240747 | Medical Diode Laser (M2-GK) | Wuhan Pioon Technology Co., Ltd. | 2024 |
| K240644 | Medical Diode Laser (S1Pro) | Wuhan Pioon Technology Co., Ltd. | 2024 |
| K212734 | Diode laser therapy device | Triangel Rsd Limited | 2023 |
Trace the full predicate network for K243037
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.