FDA.reportPublic FDA data

Dental diode laser system

Definition
A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery.
GUDID devices
297
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00628055817031ZolarZolar Technology & Mfg Co. IncPhoton EXE2026-04-09
00628055817048ZolarZolar Technology & Mfg Co. IncPhoton EXE Plus2026-04-09
00647529002292iLase Handpiece Biolase, Inc.iLase2016-09-22
00647529003176Diode Laser TipsBiolase, Inc.PI Pro Tips, Surgical, 3-42017-01-13
00647529003183Diode Laser TipsBiolase, Inc.PI Pro Tips, Surgical, 4-42017-01-13
00647529003299Diode Laser TipsBiolase, Inc.Pre-initiated, Perio, 3-72016-11-30
00647529003336Diode Laser TipsBiolase, Inc.Pre-Initiated, Perio, 4-92016-11-30
00647529003343Diode Laser TipsBiolase, Inc.Pre-initiated, Surgical, 3-42016-11-30
00872320000868Pioneer Elite Ergonomic Handpiece SleeveCAO GROUP, INC.040732017-08-17
00872320004323Picasso Tips_300um diam_5mm longCAO GROUP, INC.038042018-09-17
00872320004330Picasso Tips_400um diam_5mm longCAO GROUP, INC.038052018-09-17
00872320004347Picasso Tip_200um diam_20mm longCAO GROUP, INC.038072018-09-17
00872320004354Picasso Tips_300um diam_10mm longCAO GROUP, INC.038082018-09-17
00872320004361Picasso Tips_400um diam_10mm longCAO GROUP, INC.038092018-09-17
00872320004422Picasso Clario Diode LaserCAO GROUP, INC.C8102018-11-24
00872320004521Precise SHP 300um Fiber TipCAO GROUP, INC.030222019-09-12
00872320004538Precise SHP 400um Fiber TipCAO GROUP, INC.028242019-09-12
00872320004545Precise SHP 600um Fiber TipCAO GROUP, INC.021632019-09-12
00872320004637Pioneer Elite Perio TipCAO GROUP, INC.026562019-09-12
00872320004644Pioneer Elite Standard Fiber TipCAO GROUP, INC.026552019-09-12
00872320004842Hygea Diode LaserCAO GROUP, INC.047782019-12-03
00872320006440Picasso Pro Diode LaserCAO GROUP, INC.002-004602026-04-10
00872320006617Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.002-004802026-04-10
00872320006846LEAP Laser Delivery TipCAO GROUP, INC.050832026-04-10
00872320006853Picasso Pro Pre-initiated Laser Tip, 300um, 5mmCAO GROUP, INC.053792026-04-10
00872320006860Picasso Pro Pre-initiated Laser Tip, 300um, 10mmCAO GROUP, INC.051932026-04-10
00872320006877Picasso Pro Pre-initiated Laser Tip, 400um, 5mmCAO GROUP, INC.053802026-04-10
00872320006884Picasso Pro Pre-initiated Laser Tip, 400um, 10mmCAO GROUP, INC.051942026-04-10
00872320006891Picasso Pro Disposable Therapy Tip, StraightCAO GROUP, INC.052212026-04-10
00872320006907Picasso Pro Disposable Therapy Tip, CurvedCAO GROUP, INC.052222026-04-10
06944843604473DTEGuilin Woodpecker Medical Instrument Co., Ltd.D-Laser 162026-04-15
06944843604480DTEGuilin Woodpecker Medical Instrument Co., Ltd.D-Laser Blue2026-04-15
06944843617169WOODPECKERGuilin Woodpecker Medical Instrument Co., Ltd.Laser Smart2026-04-15
06944843617176WOODPECKERGuilin Woodpecker Medical Instrument Co., Ltd.Laser Smart Blue2026-04-15
08056093610055Doctor Smile LAMBDA SPADoctor Smile A-8102016-12-15
08056093610086Doctor SmileLAMBDA SPADoctor Smile A-810 2016-12-15
08056093610116Doctor SmileLAMBDA SPADOCTOR SMILE WISER 22018-01-30
D74666592421Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66592422018-03-14
D74666614201Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66614202018-03-14
E27664984842EasyTip 200 Pack 25 SIRONA Dental Systems GmbH64984842020-03-26
E27665359052EasyTip Endo Pack 25 SIRONA Dental Systems GmbH65359052020-03-26
E27666592832EasyTip Endo Pack 25SIRONA Dental Systems GmbH66592832020-03-26
E27666592912EasyTip 320 Pack 25 SIRONA Dental Systems GmbH66592912020-03-26
E27665716860SiroLaserSIRONA Dental Systems GmbH65716862025-09-03
06972693080109SWOTShanghai Wonderful Opto-Electrics Tech.Co.,LtdPICASSO2025-03-17
00359883006587Bluewave™ Soft Tissue Diode LaserDEN-MAT HOLDINGS, LLC4440002025-03-12
06977331780007GIGAAGigaalaser Company Ltd.GBOX-15A2024-11-30
06977331780014GIGAAGigaalaser Company Ltd.GBOX-15B2024-11-01
06977331780021GIGAAGigaalaser Company Ltd.GBOX-20B2024-11-01
06977331780038GIGAAGigaalaser Company Ltd.GBOX-15AB2024-11-01
D813ZLR3003INT0NV PRO3 DEN-MAT HOLDINGS, LLCZLR3003INT 2024-10-23
00647529004647Diode Laser TipsBiolase, Inc.Epic Q, surgical assortment kit, 30PK2024-04-29
D74666591921Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66591922018-03-14
D74666591011Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66591012018-03-14
D74666593091Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66593092018-03-14
D74666592001Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66592002018-03-14
D74666592181Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66592182018-03-14
D74666592911Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66592912018-03-14
D74666595561Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66595562018-03-14
D74666591841Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66591842018-03-14
D74666592261Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66592262018-03-14
D74666592341Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66592342018-03-14
D74666592831Sculpt I.Q.DENTSPLY SIRONA ORTHODONTICS INC.66592832018-03-14
00861407000310GeminiAZENA MEDICAL, LLC89832023-11-03
00861407000327GeminiAZENA MEDICAL, LLC89842023-11-03
00861407000334GeminiAZENA MEDICAL, LLC89852023-11-03
D813444000L0CCD BLUEWAVE LASERDEN-MAT HOLDINGS, LLC444000L 2023-10-10
08056093610284Doctor SmileLAMBDA SPADOCTOR SMILE WISER 22018-01-30
00647529000120Diode Laser TipsBiolase, Inc.perio, E3-9, single tip2023-06-19
00647529000137Diode Laser TipsBiolase, Inc.perio, E4-9, single tip2023-06-19
00647529001844Diode Laser TipsBiolase, Inc.eztips, surgical assortment kit, 30PK2023-06-19
00647529003473Epic Pro Diode Laser SystemBiolase, Inc.Dental soft tissue diode laser system refurbished2023-06-19
00647529003558Epic Pro Diode Laser SystemBiolase, Inc.Dental soft tissue diode laser system refurbished2023-06-19
00647529004159Epic Hygiene Diode Laser SystemBiolase, Inc.Handpiece, 1pk2023-06-19
00647529004166Epic Hygiene Diode Laser SystemBiolase, Inc.Laser System, Replacement2023-06-19
00647529004173Epic X Diode Laser SystemBiolase, Inc.7400073 Replacement2023-06-19
00647529004357Dental Soft Tissue Laser SystemBiolase, Inc.Epic Q Laser System2023-06-19
00366975012814STERLINGBENCO DENTAL SUPPLY CO.4983-5662023-06-13
D813LR1001WINT0SOL®DEN-MAT HOLDINGS, LLCLR1001WINT2022-09-22
D813ZLR10180SL3®DEN-MAT HOLDINGS, LLCZLR10182022-09-22