Class Class II
PALLAS Premium (K223588)
Description
PALLAS Premium by Laseroptek Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223588
Clearance Date2023-01-26
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223588
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. PALLAS Premium (K223588) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193478 | XTRAC Momentum Excimer Laser System | Strata Skin Sciences, Inc. | 2020 |
| K191501 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | 2020 |
Trace the full predicate network for K223588
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.