Class Class II
AvalancheLase Family (K223540)
Description
AvalancheLase Family by Fotona D.O.O., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223540
Clearance Date2023-01-19
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223540
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. AvalancheLase Family (K223540) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213267 | Dynamis Pro Family | Fotona D.O.O. | 2022 |
| K201111 | GentleMax Pro Plus | Candela Corporation | 2020 |
| K162886 | DEKA MOTUS AX | El.En Electronic Engineering Spa | 2017 |
| K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 |
| K140732 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | Candela Corp. | 2014 |
Trace the full predicate network for K223540
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.