Class Class II
Single Use CO2 Laser Fiber (HAF005001) (K243588)
Description
Single Use CO2 Laser Fiber (HAF005001) by Quanta System Spa, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243588
Clearance Date2025-02-19
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243588
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. Single Use CO2 Laser Fiber (HAF005001) (K243588) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203799 | ProFlex CO2 Laser Fiber | Innovaquartz, LLC | 2021 |
Trace the full predicate network for K243588
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.