Manufacturer
Jeisys Medical IncorporatedTRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
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
- K251464
- Device name
- TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
- Company
- Jeisys Medical Incorporated
- 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
1Pastelle Pro
K251464 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 K251464 as a predicate
