FDA.reportPublic FDA data

Dental solid-state laser system

Definition
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.
GUDID devices
289
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00647529000410Waterlase Laser Tips Biolase, Inc.MZ10-6 Zip Tips2016-09-16
00647529000847Waterlase Laser Tips Biolase, Inc.MZ5-3 Zip Tips2016-09-16
00647529000854Waterlase Laser TipsBiolase, Inc.MZ5-6 Zip Tips 2016-09-16
00647529000861Waterlase Laser Tips Biolase, Inc.MZ5-9 Zip Tips2016-09-15
00647529000878Waterlase Laser Tips Biolase, Inc.MZ5-14 Zip Tips2016-09-15
00647529000885Waterlase Laser Tips Biolase, Inc.MZ6-3 Zip Tips2016-09-15
00647529000892Waterlase Laser TipsBiolase, Inc.MZ6-6 Zip Tips2016-09-15
00647529000908Waterlase Laser TipsBiolase, Inc.MZ6-9 Zip Tips2016-09-15
00647529000915Waterlase Laser TipsBiolase, Inc.MZ6-14 Zip Tips2016-09-15
00647529001035Waterlase Laser TipsBiolase, Inc.RFPT8-102016-09-16
00647529001042Waterlase Laser TipsBiolase, Inc.RFT2-212016-09-16
00647529001059Waterlase Laser TipsBiolase, Inc.RFT2-252016-09-16
00647529001066Waterlase Laser TipsBiolase, Inc.RFT3-172016-09-16
00647529001073Waterlase Laser TipsBiolase, Inc.RFT3-212016-09-16
00647529001103Waterlase Laser Tips Biolase, Inc.Z2-142016-09-16
00647529001127Waterlase Laser Tips Biolase, Inc.Z2-202016-09-16
00647529001141Waterlase Laser Tips Biolase, Inc.Z2-252016-09-16
00647529001158Waterlase Laser Tips Biolase, Inc.Z2-282016-09-16
00647529001189Waterlase Laser Tips Biolase, Inc.Z3-142016-09-16
00647529001196Waterlase Laser Tips Biolase, Inc.Z3-182016-09-16
00647529001202Waterlase Laser Tips Biolase, Inc.Z3-202016-09-16
00647529001219Waterlase Laser Tips Biolase, Inc.Z3-222016-09-16
00647529001226Waterlase Laser Tips Biolase, Inc.Z3-252016-09-16
00647529001233Waterlase Laser Tips Biolase, Inc.Z3-282016-09-16
00647529001240Waterlase Laser Tips Biolase, Inc.Z4-92016-09-16
00647529001257Waterlase Laser Tips Biolase, Inc.Z4-142016-09-16
00647529001264Waterlase Laser Tips Biolase, Inc.Z4-182016-09-16
00647529001271Waterlase Laser Tips Biolase, Inc.Z4-202016-09-16
00647529001288Waterlase Laser Tips Biolase, Inc.Z4-222016-09-16
00647529001295Waterlase Laser Tips Biolase, Inc.Z4-252016-09-16
00647529001301Waterlase Laser Tips Biolase, Inc.Z4-282016-09-16
00647529001349Waterlase Laser Tips Biolase, Inc.Z6-142016-09-16
00647529001356Waterlase Laser Tips Biolase, Inc.Z6-62016-09-16
00647529001363Waterlase Laser Tips Biolase, Inc.Z2-332016-09-16
00647529001394Waterlase Laser Tips Biolase, Inc.G6-42016-09-16
00647529001400Waterlase Laser Tips Biolase, Inc.G6-62016-09-16
00647529001417Waterlase Laser Tips Biolase, Inc.G6-92016-09-16
00647529001431Waterlase Laser Tips Biolase, Inc.S75-62016-09-16
00647529001448Waterlase Laser Tips Biolase, Inc.Z6-92016-09-16
00647529001462Waterlase Laser Tips Biolase, Inc.C3-92016-09-16
00647529001479Waterlase Laser Tips Biolase, Inc.C6-92016-09-16
00647529001486Waterlase Laser Tips Biolase, Inc.C12-92016-09-16
00647529001516Waterlase Laser TipsBiolase, Inc.RFPT8-142016-09-16
00647529002223Waterlase Laser TipsBiolase, Inc.MZ8-6 ZipTips2016-09-16
00647529003732Waterlase Laser TipsBiolase, Inc.LaserFresh Sapphire Tip, Single Bagged Tip, Single2023-08-01
00647529003756Waterlase iPlus Dental Laser SystemBiolase, Inc.Fractional Handpiece Kit2023-08-01
00647529004128Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, racing red pr2024-02-22
00647529004265Waterlase Laser TipsBiolase, Inc.Tip, MZ6-17mm2023-06-12
00647529004364Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, gloss black p2024-02-22
00647529004371Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system , midnight blu2024-02-22
00647529004388Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system , bright lime 2024-02-22
00647529004395Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, burnt orange 2024-02-22
00647529004401Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, platinum, pre2024-02-22
00647529004418Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, purple w/ C&V2024-02-22
00647529004425Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, yellow premie2024-02-22
00647529004432Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, aquarium prem2024-02-22
00647529004449Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, jungle premie2024-02-22
00647529004456Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, rose gold pre2024-02-22
00647529542019Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system,pearl white, p2024-02-22
00818365026456EdgePRO™US ENDODONTICS, LLC64004632023-06-25
00818365026555EdgePRO™US ENDODONTICS, LLC62002102023-06-25
00818365026661EdgePRO™US ENDODONTICS, LLC72300152023-06-25
00818365026678EdgePRO™US ENDODONTICS, LLC72300092023-06-25
00818365026685EdgePRO™US ENDODONTICS, LLC72300102023-06-25
00818365026692EdgePRO™US ENDODONTICS, LLC72300112023-06-25
00818365026708EdgePRO™US ENDODONTICS, LLC72300122023-06-25
00818365026715EdgePRO™US ENDODONTICS, LLC72300082023-06-25
00857848007674InPulse Dental LaserBeyond International Inc.InPulse Touch 1002022-12-23
07290016784039D-STORMLIGHT INSTRUMENTS LTD12023-01-08
07290016784046D-STORMLIGHT INSTRUMENTS LTD12023-01-08
08057017760054DEKA SMARTFILEEL.EN. SPAM077C22017-02-23
08404535014655EdgeProPeter Brasseler Holdings, LLCEDGEPRO-22026-04-06
00647529004722Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, red SG22025-01-31
00647529004777Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, platinum SG22025-01-31
03830054230927SkyPulseFOTONA d.o.o.M321-A2024-10-04
03830054230934SkyPulseFOTONA d.o.o.M321-B2024-10-04
03830054237629TimeWalker ATFOTONA d.o.o.M021-5AF/12024-09-19
03830054237636TimeWalker ST-EFOTONA d.o.o.M002-6A/22024-09-19
03830054237681LightWalker AT SFOTONA d.o.o.M021-5AF/1 S2024-09-19
03830054237698LightWalker ST-E PROFOTONA d.o.o.M002-6A/2 PRO2024-09-19