510(k) Report

Devices descending from K053047

205 later devices reach Fraxel SR Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+11K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+11K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+11K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+11K252215InbellaMAX SystemInbella Medical, Ltd.20250—