# K251464: TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical Incorporated
- Decided: Oct 3, 2025 after 143 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 29 generations back to K943450 (1995). 306 ancestors in all.
No later device cites it as a predicate yet.
0 of 307 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241527: Pastelle Pro, Wontech Co., Ltd. (2025) Summary page 6.

## 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

Source page: https://510kreport.com/device/K251464
Methodology: https://510kreport.com/methodology