Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (K241057)
Description
Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) by Wuhan Guangdun Technology Co.,Ltd.., an FDA 510(k) cleared physical medicine device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241057
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. Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (K241057) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K130996 | ERCHONIA EMERGE | Erchonia Medical, Inc. | 2013 |
| K050668 | GRT LITE, MODEL 8-A | Grt Solutions, Inc. | 2006 |
| K030226 | THOR DDII 830CL3 LASER SYSTEM | Thor Intl. | 2003 |
| K012580 | ERCHONIA PL2000 | Tuco Innovations, Inc. | 2002 |
Trace the full predicate network for K241057
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.