510(k) Report

Devices descending from K861688

110 later devices reach Xanar CO2 Surgical Laser System Model Xap-15 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251632Optimas MAX SystemInMode, Ltd.20251—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—