TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)

Jeisys Medical Incorporated

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

Product code GEX· 21 CFR 878.4810

View Summary PDF

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
K251464
Device name
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-05-13
Decision date
2025-10-03
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The TRI-BEAM PRO, TRI-BEAM, Nd: YAG Laser Unit is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 1064 Wavelength in G, TH mode:
- Tattoo removal: dark ink (black, blue and brown)
- Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation.
- Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkle
- Treatment of melasma
1064nm in GN (PTP-Off) mode:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
- Removal of Epidermal benign Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines;
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus

Intended Use

The TRI-BEAM PRO, TRI-BEAM, Nd: YAG Laser Unit is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 1064 Wavelength in G, TH mode: - Tattoo removal: dark ink (black, blue and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation. - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkle - Treatment of melasma 1064nm in GN (PTP-Off) mode: - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces): - Tattoo removal: light ink (red,tan, purple, orange, sky blue,green) - Removal of Epidermal benign Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Treatment of Lentigines; - Treatment of Cafe-Au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper-Pigmentation - Treatment of Becker's Nevi, Freckles and Nevi Spilus

Device Description

TRI-BEAM PRO, Nd:YAG Laser unit in the wavelength 1064 nm, 532 nm, 585 nm, and 650 nm is intended for treatment for general dermatology. The TRI-BEAM Series, utilizing Nd:YAG laser optical energy, is based on the principle of selective photothermolysis, enabling targeted treatment of pigmented and vascular lesions, tattoos, wrinkles, acne, and other dermatologic conditions while minimizing damage to surrounding tissue. The system comprises the main unit, a color touch screen, a handpiece, and a foot switch. Handpiece Mode PTP_ON: Single Pulse Laser energy is delivered to the target tissue as a single, continuous pulse. PTP_OFF: Dual Pulse One pulse is divided into two sub-pulses, delivered sequentially with a short time interval to reduce peak thermal load. G Mode Beam profile with energy concentrated at the center and gradually tapering toward the periphery, allowing focal energy delivery. TH Mode Flat-top energy distribution in which the output intensity at the center and periphery is nearly uniform, ensuring consistent tissue exposure. GN Mode Flat-top energy distribution designed to minimize strong irritation to the skin, even when applied at higher energy levels.

Summary parsed at:2026-06-01 05:23:19 UTC

Predicate devices

1

K251464 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K251464 as a predicate