Class Class II
LightWalker Laser System Family (K242202)
Description
LightWalker Laser System Family by Fotona D.O.O., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242202
Clearance Date2024-08-23
Clearance TypeSpecial
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242202
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. LightWalker Laser System Family (K242202) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021 |
Trace the full predicate network for K242202
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.