Manufacturer
BLUECORE COMPANY Co., Ltd.Lasya-Trinity
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K241951
- Device name
- Lasya-Trinity
- Company
- BLUECORE COMPANY Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-07-03
- Decision date
- 2024-10-10
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatmentHair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Lasya-Trinity diode laser system is intended for use in dermatology procedures requiring coagulation with the following indications: - The trinity applicator is indicated for benign vascular and vascular dependent lesions. - The 808 applicator is indicated for permanent reduction in hair regrowth. Use on all skin types (Fitzpatric I-VI), including tanned skin.
Intended Use
The Lasya-Trinity diode laser system is intended for use in dermatology procedures requiring coagulation with the following indications: The trinity applicator is indicated for benign vascular and vascular dependent lesions. The 808 applicator is indicated for permanent reduction in hair regrowth. Use on all skin types (Fitzpatric I-VI), including tanned skin.
Device Description
The Lasya-Trinity is a diode laser instrument that uses diode as a medium to emit a laser beam of 755, 808, and 1064 nm wavelengths. It includes two handpieces, allowing user selection, and is controlled by specific software through a touchscreen display. The system is intended for use in facilities such as hospitals, physicians' offices, and medical spas. Its major components include the main console unit, foot switch, and individual modules. The device is reusable and non-sterile, with instructions for cleaning its components provided in the labeling. The system consists of: System console (contains the system software, power supply, and various other electronic and mechanical parts), Operator control panel with touch-screen technology (GUI), Trinity applicator (handpiece) with 1064 nm, 808 nm, and 755 nm wavelengths applied simultaneously, 808 applicator (handpiece) with 808 nm wavelength, Footswitch, and other components.
Summary parsed at:2026-06-01 05:28:55 UTC
Predicate devices
1The Alma Soprano Titanium
K241951 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K241951 as a predicate
