510(k) Report

Devices descending from K091320

12 later devices reach Spectra SP II, Spectra Denta II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132661LightscalpelLightscalpel, LLC20143—
+1K123494SOLEAConvergent Dental, Inc.201331
+1K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+2K244060eCO2 3DLutronic Corporation20250—
+2K151306SoleaConvergent Dental, Inc.20151—
+2K141658Light ScalpelLightscalpel, LLC20142—
+2K130420SOLEAConvergent Dental, Inc.201321
+2K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+3K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+3K221761SoleaConvergent Dental, Inc.202201
+3K173827LightScalpelLightscalpel, LLC20180—
+3K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—