Class Class II
Medical diode laser systems (CHARISMA, REGAL) (K234004)
Description
Medical diode laser systems (CHARISMA, REGAL) by Reveal Lasers , Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234004
Clearance Date2025-02-20
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234004
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. Medical diode laser systems (CHARISMA, REGAL) (K234004) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230077 | LaserME | Neauvia North America | 2023 |
| K193656 | SkyPulse | Fotona D.O.O. | 2020 |
| K160549 | MEDICAL DIODE LASER SYSTEMS | Wuhan Gigaa Optronics Technology Co... | 2017 |
| K160952 | Alma Diode Tabletop Laser | Alma, Ltd. | 2016 |
| K140470 | OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE... | Oberon GmbH Fiber Technologies | 2014 |
Trace the full predicate network for K234004
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.