Class Class II
Alma Harmony (K230308)
Description
Alma Harmony by Alma Lasers, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230308
Clearance Date2023-03-01
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230308
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. Alma Harmony (K230308) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 |
| K181298 | Harmony XL Multi-Application Platform | Alma Lasers, Inc. | 2018 |
| K141237 | HARMONY LITE | Alma, Inc. | 2015 |
| K072564 | ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM | Alma Lasers , Ltd. | 2008 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233024 | Alma Harmony | Alma Lasers, Inc. | 2024 |
Trace the full predicate network for K230308
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.