510(k) Report

Devices descending from K090181

26 later devices reach Waterlase MD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+2K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+2K161669Waterlase ExpressBiolase, Inc.201621—
+2K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+3K213428EdgeProBiolase, Inc.20210—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+3K150664NeoLasSheaumann Laser, Inc.20151—
+4K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—