Class Class II
Myolight Microcurrent Handpiece (K243063)
Description
Myolight Microcurrent Handpiece by Raja Trading Company, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243063
Clearance Date2025-02-10
Clearance TypeTraditional
Product CodeNFO
Regulation Number882.5890
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243063
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. Myolight Microcurrent Handpiece (K243063) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232172 | BTL-785BNF Handpiece | BTL Industries, Inc. | 2023 |
| K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT... | Avazzia, Inc. | 2021 |
Trace the full predicate network for K243063
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.