FDA.reportPublic FDA data

510(k) K263063

Device
B`orze Inc Laser Family (Sorren/Adonis)
Applicant
Borze, Inc.
510(k) number
K263063
Product code
GEX
Decision
Substantially Equivalent (SESE)
Decision date
2026-10-30
Date received
2026-09-01
Regulation
878.4810
Classification name
Powered Laser Surgical Instrument
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Rex Howard Frazier
Address
950 W Bannock, Suite 1100, Boise, Id 83702 Usa Boise ID US 83702 83702

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GEX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262349Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI)Risu Medical Technology Co., Ltd.2026-10-27
K262627Fractional CO2 Laser Therapy System (Z121)Sanhe PERFECTLASER Technology Co., Ltd.2026-10-26
K262701PicoPeak Picosecond Nd:Yag Laser System (Bella-9)Beijing Sea Heart International Science and Technologyco.Ltd2026-10-22
K262628Picosecond Laser treatment system (Z180)Sanhe PERFECTLASER Technology Co., Ltd.2026-10-20
K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd.2026-10-13
K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)Wuhan Phomed Technology Co., Ltd.2026-10-08
K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd.2026-10-07
K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.2026-09-24
K241973SmartIPL_NI SystemLumenis Be, Ltd.2026-09-19
K252723Dynamis Pro FamilyFotona D.O.O.2026-09-19
K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.2026-09-18
K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.2026-09-17
K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.2026-09-17
K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America2026-09-16
K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.2026-09-10