510(k) Report

Devices descending from K081015

34 later devices reach Ceralas D 980NM Diode Laser, Models D15 and D25 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+1K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+1K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+1K094049Stlase Diode LaserDental Photonics, Inc.201023—
+1K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+1K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+2K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+2K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+2K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+2K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+2K111689StlaseDental Photonics, Inc.201222—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+3K163128Epic ProBiolase, Inc.201716—
+3K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+4K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+4K193656SkyPulseFotona D.O.O.202011—
+4K172771Epic Pro 940Biolase, Inc.20171—
+4K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+5K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K200693K2 MobileHulaser, Inc.20202—
+6K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—