FDA.reportPublic FDA data

GIGAA

Primary DI
06977331780014
Brand
GIGAA
Company
Gigaalaser Company Ltd.
Model
GBOX-15B
Published
2024-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NVKLaser, Dental, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVKLaser, Dental, Soft TissueGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230047000Medical Diode Laser SystemsGigaalaser Company , Ltd.2024-03-04NVK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977331780014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977331780014069773317800146977331780014

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

Regulatory Flags#

DUNS number
618495205
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16977331780080GigaaMedGBOX-15D2026-03-19
16977331780059GIGAACHEESEII-10B2025-08-15
16977331780011GIGAAGBOX-20B2025-08-13
16977331780028GIGAAVELASII-30A2025-08-13
16977331780035GIGAAVELASII-30B2025-08-13
16977331780042GIGAAGBOX-15AB 2025-08-13
06977331780007GIGAAGBOX-15A2024-11-30
06977331780021GIGAAGBOX-20B2024-11-01
06977331780038GIGAAGBOX-15AB2024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944843604473DTEGuilin Woodpecker Medical Instrument Co., Ltd.NVK2026-04-15
06944843604480DTEGuilin Woodpecker Medical Instrument Co., Ltd.NVK2026-04-15
06944843617169WOODPECKERGuilin Woodpecker Medical Instrument Co., Ltd.NVK2026-04-15
06944843617176WOODPECKERGuilin Woodpecker Medical Instrument Co., Ltd.NVK2026-04-15
00872320006440Picasso Pro Diode LaserCAO GROUP, INC.NVK2026-04-10
00872320006617Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.NVK2026-04-10
00872320006846LEAP Laser Delivery TipCAO GROUP, INC.NVK2026-04-10
00872320006853Picasso Pro Pre-initiated Laser Tip, 300um, 5mmCAO GROUP, INC.NVK2026-04-10
00872320006860Picasso Pro Pre-initiated Laser Tip, 300um, 10mmCAO GROUP, INC.NVK2026-04-10
00872320006877Picasso Pro Pre-initiated Laser Tip, 400um, 5mmCAO GROUP, INC.NVK2026-04-10
00872320006884Picasso Pro Pre-initiated Laser Tip, 400um, 10mmCAO GROUP, INC.NVK2026-04-10
00872320006891Picasso Pro Disposable Therapy Tip, StraightCAO GROUP, INC.NVK2026-04-10
00872320006907Picasso Pro Disposable Therapy Tip, CurvedCAO GROUP, INC.NVK2026-04-10
08404535014655EdgeProPeter Brasseler Holdings, LLCNVK2026-04-06
06974624062116PIOONWuhan Pioon Technology Co., Ltd.NVK2025-07-08
06974624062109PIOONWuhan Pioon Technology Co., Ltd.NVK2025-07-07
06977331780007GIGAAGigaalaser Company Ltd.NVK2024-11-30
06977331780021GIGAAGigaalaser Company Ltd.NVK2024-11-01
06977331780038GIGAAGigaalaser Company Ltd.NVK2024-11-01
08059340290000Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290017Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290024Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290031Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290048Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290055Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290062Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290079Primo Dental LaserMEDENCY SRLNVK2024-04-10
00818365026456EdgePRO™US ENDODONTICS, LLCNVK2023-06-25
00818365026555EdgePRO™US ENDODONTICS, LLCNVK2023-06-25
00818365026661EdgePRO™US ENDODONTICS, LLCNVK2023-06-25