FDA.reportPublic FDA data

Dental Diode Laser System

Primary DI
06970750060163
Brand
Dental Diode Laser System
Company
LAZON Medical Laser Co., Ltd.
Model
SOLASE-976
Catalog number
08
Published
2019-01-08
Public version status
New
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
K180967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180967000Dental Diode Laser SystemLazon Medical Laser Co., Ltd.2018-07-11GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970750060163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970750060163069707500601636970750060163

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
544395883
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970750060019Dental Diode Laser SystemSOLASE-808012019-01-08
06970750060026Dental Diode Laser SystemSOLASE-808022019-01-08
06970750060033Dental Diode Laser SystemSOLASE-808032019-01-08
06970750060040Dental Diode Laser SystemSOLASE-808042019-01-08
06970750060057Dental Diode Laser SystemSOLASE-808052019-01-08
06970750060064Dental Diode Laser SystemSOLASE-808062019-01-08
06970750060071Dental Diode Laser SystemSOLASE-808072019-01-08
06970750060088Dental Diode Laser SystemSOLASE-808082019-01-08
06970750060095Dental Diode Laser SystemSOLASE-976012019-01-08
06970750060101Dental Diode Laser SystemSOLASE-976022019-01-08
06970750060118Dental Diode Laser SystemSOLASE-976032019-01-08
06970750060125Dental Diode Laser SystemSOLASE-976042019-01-08
06970750060132Dental Diode Laser SystemSOLASE-976052019-01-08
06970750060149Dental Diode Laser SystemSOLASE-976062019-01-08
06970750060156Dental Diode Laser SystemSOLASE-976072019-01-08

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Primary DI, Brand, Company table
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08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
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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
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08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16