Manufacturer
Reveal Lasers , Ltd.Medical diode laser systems (CHARISMA, REGAL)
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K234004
- Device name
- Medical diode laser systems (CHARISMA, REGAL)
- Company
- Reveal Lasers , Ltd.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-12-19
- Decision date
- 2025-02-20
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Skin resurfacingPigment treatmentSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
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.
Intended 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.
Device Description
Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470nm. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.
Summary parsed at:2026-06-01 05:20:59 UTC
Predicate devices
6—
—
Not ingested
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—
Not ingested
MEDICAL DIODE LASER SYSTEMS
Alma Diode Tabletop Laser
SkyPulse
LaserME
K234004 references 6 predicate/reference devices
Cited as predicate
1The Botticelli (Model: Athena)
1 submission cite K234004 as a predicate
