510(k) Report

Devices descending from K050254

13 later devices reach Spectra-SP CO2 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+2K132661LightscalpelLightscalpel, LLC20143—
+2K123494SOLEAConvergent Dental, Inc.201331
+2K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+3K244060eCO2 3DLutronic Corporation20250—
+3K151306SoleaConvergent Dental, Inc.20151—
+3K141658Light ScalpelLightscalpel, LLC20142—
+3K130420SOLEAConvergent Dental, Inc.201321
+3K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+4K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+4K221761SoleaConvergent Dental, Inc.202201
+4K173827LightScalpelLightscalpel, LLC20180—
+4K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—