Class Class II
The Alma Soprano Titanium (K230371)
Description
The Alma Soprano Titanium by Alma Lasers, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230371
Clearance Date2023-02-22
Clearance TypeSpecial
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230371
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 Soprano Titanium (K230371) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241951 | Lasya-Trinity | BLUECORE COMPANY Co., Ltd. | 2024 |
| K231896 | Diode Laser Therapy System | Beijing Adss Development Co., Ltd. | 2024 |
Trace the full predicate network for K230371
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.