510(k) Report

Devices descending from K103654

14 later devices reach Vela XL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202106Plasmage SystemBrera Medical, Inc.20220—
+1K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+2K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser…C.R. Bard, Inc.20260—
+2K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+2K251824Patriot DuoPatriot Laser, LLC20250—
+2K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+2K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+2K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+3K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+3K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+4K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20261—
+4K251100Ipgtfl-02Ipg Medical Corporation20250—
+4K250504Leonardo DusterCeramoptec GmbH20250—
+5K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20260—