FDA.report

Dental Diode Laser System

Primary DI
06970750060040
Brand
Dental Diode Laser System
Company
LAZON Medical Laser Co., Ltd.
Model
SOLASE-808
Catalog number
04
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
06970750060040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06970750060040069707500600406970750060040

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
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
06970750060163Dental Diode Laser SystemSOLASE-976082019-01-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08052286590500LASER THERMAL THERAPY KIT S EELESTA SPAGEX2026-03-24
08052286590517LASER THERMAL THERAPY KIT L EELESTA SPAGEX2026-03-24
06975617991024DIODE LASER FOR HIAR REMOVALBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617992014Q-SWITCHED ND:YAG LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617993011CO2 FRACTIONAL LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
16977331780080GigaaMedGigaalaser Company Ltd.GEX2026-03-19
02816901023318NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
02816901024032NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
01816901024156NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
00860015460615NextGen Aesthetics CO2T AESTHETICS LLCGEX2026-03-12
00860015460639NextGen Aesthetics LHRT AESTHETICS LLCGEX2026-03-12
08034108512877TORODEKA M.E.L.A. SRLGEX2026-03-11
00850069558574Lithoblast Single-Use Holmium Laser FibersDAWELL MEDICAL, LLCGEX2026-03-10
00850069558109Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558116Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558123Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558550Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558567Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558581Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558598Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558604Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558611Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558628Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558635Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558642Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558659Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558666Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558673Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558680Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558697Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02