Lasya-Trinity

BLUECORE COMPANY Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K241951
Device name
Lasya-Trinity
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

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