510(k) Report

Devices descending from K992866

118 later devices reach Optilite IX Laser Surgery Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K22079410PLTentech Co., Ltd.20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—