FDA.report

Dental Diode Laser System

Primary DI
06970750060118
Brand
Dental Diode Laser System
Company
LAZON Medical Laser Co., Ltd.
Model
SOLASE-976
Catalog number
03
Published
2019-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K180967000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06970750060118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06970750060118069707500601186970750060118

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
544395883
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 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
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
06970750060163Dental Diode Laser SystemSOLASE-976082019-01-08

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