510(k) Report

Devices descending from K042211

303 later devices reach Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—