FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm (K221623)
Description
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm by Gme German Medical Engineering GmbH, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221623
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. FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm (K221623) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203054 | FlexSys | Gme German Medical Engineering GmbH | 2021 |
| K191086 | Exciplex | Clarteis | 2019 |
| K171702 | Exciplex308nm | Clarteis | 2017 |
| K150752 | GME ExSys 308 | Gme (German Medical Engineering) GmbH | 2015 |
| K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM | Solta Medical, Inc. | 2013 |
Trace the full predicate network for K221623
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.