FDA.reportPublic FDA data

Doctor Diode Laser

Primary DI
18056093611028
Brand
Doctor Diode Laser
Company
LAMBDA SPA
Model
Optical tip
Catalog number
LATSU302.4
Device description
Doctor Diode Laser/ Optical Tip LATSU302.4 (Doctor Smile - Wiser Tip) is used in surgery applications
Published
2016-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K102036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102036000DOCTOR SURGERY DIODE LASERS FAMILYLambda S.P.A.2010-09-28GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056093611028PackageGS14In Commercial Distribution
08056093611021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805609361102818056093611028
08056093611021080560936110218056093611021

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
428482616
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
18056093611035Doctor Diode LaserOptical tipLATIM302.42016-12-01
18056093611042Doctor Diode LaserOptical tipLATHE402.42016-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16