FDA.reportPublic FDA data

Doctor Smile

Primary DI
08056093610055
Brand
Doctor Smile
Company
LAMBDA SPA
Model
Doctor Smile A-810
Device description
Doctor Smile A-810 laser ( DOCTOR SMILE D5 810 nm) is a standard diode medical laser with 810 nm walelength. It is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening, Intra and extra oral surgery incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue curettage, whitening.
Published
2016-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091562000DOCTOR SMILE A-810 AND B-980 LASERSLambda Scientific Spa2009-09-08GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056093610055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056093610055080560936100558056093610055

GMDN Terms#

Term, Definition table
TermDefinition
Dental diode laser systemA 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.

Regulatory Flags#

DUNS number
428482616
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056093610024Doctor Diode LaserDoctor Smile2016-12-01
08056093610062Doctor SmileDoctor Smile B-9802016-12-15
08056093610093Doctor SmileDoctor Smile B-980LA5D0001.22016-12-15
08056093610109Doctor Diode LaserDoctor Smile LA3D0001.32016-12-01
08056093610284Doctor SmileDOCTOR SMILE WISER 2LA8D0001.32018-01-30
08056093611014Doctor Diode LaserOptical tipLATPA402.42016-12-01
08056093611021Doctor Diode LaserOptical tipLATSU302.42016-12-01
08056093611038Doctor Diode LaserOptical tipLATIM302.42016-12-01
08056093611045Doctor Diode LaserOptical tipLATHE402.42016-12-01
08056093611113Doctor Diode LaserTip ENTLATNT601.102016-12-15
08056093611007Doctor Diode LaserOptical tipLATEN202.42016-12-01
08056093611137Doctor SmileHandpieceLOMAN009.22016-12-15
08056093611052Doctor SmileFiber opticLAFIO002.32016-12-15
08056093611069Doctor SmileFiber opticLAFIO003.32016-12-15
08056093611076Doctor SmileFiber opticLAFIO0042.32016-12-15
08056093611083Doctor SmileFiber opticLAFIO006.32016-12-15
08056093611120Doctor SmileHandpieceLAFIO0025.12016-12-15
18056093611011Doctor Diode LaserOptical tipLATPA402.42016-12-01
18056093611028Doctor Diode LaserOptical tipLATSU302.42016-12-01
18056093611035Doctor Diode LaserOptical tipLATIM302.42016-12-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14