FDA.report

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
217
Last updated
2025-02-10 08:58:35

Related Product Codes

CodeDeviceSpecialtyClassDevices
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2192
NVKLaser, Dental, Soft TissueGeneral, Plastic Surgery225

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
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
03830054237704LightWalker ST-E ADVANCEDFOTONA d.o.o.M002-6A/2 ADVANCED2024-09-19
00647529003749Waterlase Laser TipsBiolase, Inc.LaserFresh Sapphire Tip, Single Bagged Tip, Single2023-08-01
00647529003770Waterlase iPlus Dental Laser SystemBiolase, Inc.Fractional Handpiece Kit2023-08-01
00647529003787Waterlase iPlus Dental Laser SystemBiolase, Inc.LaserFresh Accessory Kit Bundle2023-08-01
00818365026463EdgePRO™US ENDODONTICS, LLCBasket2023-06-25
00818365026470EdgePRO™US ENDODONTICS, LLC72100112023-06-25
00818365026494EdgePRO™US ENDODONTICS, LLC72400042023-06-25
00818365026500EdgePRO™US ENDODONTICS, LLC72400052023-06-25
00818365026517EdgePRO™US ENDODONTICS, LLC62000122023-06-25
00818365026524EdgePRO™US ENDODONTICS, LLC72200072023-06-25
00818365026548EdgePRO™US ENDODONTICS, LLC62002092023-06-25
00818365026562EdgePRO™US ENDODONTICS, LLC32001052023-06-25
00818365026579EdgePRO™US ENDODONTICS, LLC62001112023-06-25
00818365026586EdgePRO™US ENDODONTICS, LLC22001992023-06-25
00818365026593EdgePRO™US ENDODONTICS, LLC62018122023-06-25
00818365026609EdgePRO™US ENDODONTICS, LLC22010782023-06-25
00818365026623EdgePRO™US ENDODONTICS, LLC60010292023-06-25
00818365026630EdgePRO™US ENDODONTICS, LLC72100022023-06-25
00818365026647EdgePRO™US ENDODONTICS, LLC22006962023-06-25
00818365026654EdgePRO™US ENDODONTICS, LLC42002182023-06-25
00818365026722EdgePRO™US ENDODONTICS, LLC62001942023-06-25
10818365026453EdgePRO™US ENDODONTICS, LLC64004632023-06-25
10818365026552EdgePRO™US ENDODONTICS, LLC62002102023-06-25
10818365026668EdgePRO™US ENDODONTICS, LLC72300152023-06-25
10818365026675EdgePRO™US ENDODONTICS, LLC72300092023-06-25
10818365026682EdgePRO™US ENDODONTICS, LLC72300102023-06-25
10818365026699EdgePRO™US ENDODONTICS, LLC72300112023-06-25
10818365026705EdgePRO™US ENDODONTICS, LLC72300122023-06-25
10818365026712EdgePRO™US ENDODONTICS, LLC72300082023-06-25
00647529000687Waterlase Laser Tips Biolase, Inc.MZ6-4 2023-06-19
00647529000922Waterlase Laser Tips Biolase, Inc.MZ6-122023-06-19
00647529001509Waterlase Express Handpiece Biolase, Inc.Handpiece, Single Unpacked2023-06-19
00647529001974Waterlase Laser Tips Biolase, Inc.MZ10-9 Zip Tips2023-06-19
00647529002230Waterlase Laser TipsBiolase, Inc.MZ8-9 ZipTips2023-06-19
00647529002674Waterlase MD Turbo Laser SystemBiolase, Inc.7200401 Refurbished2023-06-19
00647529003008Waterlase Laser Tips Biolase, Inc.C6-4, single2023-06-19
00647529003015Waterlase Laser Tips Biolase, Inc.C6-6, single2023-06-19
00647529003282Waterlase MDX 450 Laser System Biolase, Inc.7200860-01P Certified Preowned2023-06-19
00647529003466Waterlase Express All-Tissue Laser SystemBiolase, Inc.Waterlase Express laser refurbished2023-06-19
00647529003480Waterlase Express Handpiece Biolase, Inc.Handpiece, 1PK, refurbished2023-06-19
00647529003633Waterlase iPlus Dental Laser SystemBiolase, Inc.Fractional Handpiece Kit2023-06-19
00647529003831Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system,pearl white wi2023-06-19
00647529003848Waterlase iPlus Dental Laser SystemBiolase, Inc.All Tissue YSGG dental laser system, racing red w/2023-06-19
00647529003855Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, gloss black w2023-06-19
00647529003862Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system , midnight blu2023-06-19
00647529003879Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system , bright lime,2023-06-19
00647529003886Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, burnt orange 2023-06-19
00647529003893Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, platinum, w/ 2023-06-19
00647529003909Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, purple w/ C&V2023-06-19
00647529003916Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, yellow w/ C&V2023-06-19
00647529003923Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, aquarium w/ C2023-06-19
00647529003930Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, jungle w/ C&V2023-06-19
00647529003947Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, fish w/ C&V i2023-06-19
00647529003954Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, zebra w/ C&V 2023-06-19
00647529004135EdgeProBiolase, Inc.EdgePro Laser System (Juno)2023-06-19
00647529004241EdgeProBiolase, Inc.EdgePro Handpiece2023-06-19
00647529004340Waterlase iPlus Dental Laser SystemBiolase, Inc.All tissue YSGG dental laser system, rose gold w/ 2023-06-19
00647529003763Waterlase Laser TipsBiolase, Inc.RFT2-172023-06-12
00647529003800Waterlase Express Biolase, Inc.Waterlase Express Tip Starter Kit, 37pk2023-06-12
00647529004258Waterlase Laser TipsBiolase, Inc.Tip, MZ6-17mm2023-06-12
07290016784008TIP for LITETOUCHLIGHT INSTRUMENTS LTDD-1.0 mm L-10 mm2022-12-01
07290016784053TIP for LITETOUCHLIGHT INSTRUMENTS LTDD-0.8 mm L-8 mm2022-12-01
07290016784060TIP for LITETOUCHLIGHT INSTRUMENTS LTDENDO 2022-12-01
04719882550034LightMedLIGHTMED DENTAL TECHNOLOGY CORPORATIONSA-108-A22022-07-13
08057017760528DEKA SMARTPERIOEL.EN. SPAM128A12022-04-05
03830054230507TimeWalker ATFOTONA d.o.o.M021-5AF/12021-12-01
03830054230514TimeWalker ST-EFOTONA d.o.o.M002-6A/22021-12-01
04719882550010LightMedLIGHTMED DENTAL TECHNOLOGY CORPORATIONSaphhire2021-03-20
03830054230392SkyPulseFOTONA d.o.o.M321-A2020-06-23
03830054230408SkyPulseFOTONA d.o.o.M321-B2020-06-23
03830054230347LightWalker ST-E ADVANCEDFOTONA d.o.o.M002-6A/2 ADVANCED2017-05-30
03830054230996LightWalker ST-E PROFOTONA d.o.o.M002-6A/2 PRO2017-05-30