# K234004: Medical diode laser systems (CHARISMA, REGAL)

- Pathway: 510(k) (Traditional)
- Applicant: Reveal Lasers, Ltd.
- Decided: Feb 20, 2025 after 429 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K943450 (1995). 661 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 663 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230077: LaserME, Neauvia North America (2023) Summary page 5.
- K193656: SkyPulse, Fotona D.O.O. (2020) Summary page 6.
- K160952: Alma Diode Tabletop Laser, Alma, Ltd. (2016) Summary page 6.

## Most influential descendants
- K251699: The Botticelli (Model: Athena) (2025), 0 descendants of its own

## Indications for use
The intended use of the “CHARISMA” is: -Dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines. -Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue -Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux -Further indicated for laser assisted lipolysis. The intended use of the “REGAL” is: -Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue -Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux -Further indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K234004
Methodology: https://510kreport.com/methodology