Class Class II
The Alma Hybrid Laser System (K251230)
Description
The Alma Hybrid Laser System by Alma Lasers, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251230
Clearance Date2025-05-21
Clearance TypeSpecial
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251230
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. The Alma Hybrid Laser System (K251230) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230441 | EMPOWR Stem Extender, 50mm | Encore Medical, L.P Dba Enovis | 2023 |
| K203441 | The Alma Hybrid Laser System | Alma Lasers , Ltd. | 2021 |
| K103501 | ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACC... | Alma Lasers, Inc. | 2011 |
Trace the full predicate network for K251230
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.