FDA.reportPublic FDA data

InnoVoyce Laser Fiber

Primary DI
00860004755944
Brand
InnoVoyce Laser Fiber
Company
Innovoyce LLC
Model
A
Catalog number
ASY-300063-600
Device description
InnoVoyce Laser Fiber .600 1 Pack
Published
2023-12-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K220793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220793000InnoVoyce Laser FiberInnovoyce, LLC2022-05-25GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004755975PackageGS15Not in Commercial Distribution
00860004755944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004755975008600047559758600047559750860004755975
00860004755944008600047559448600047559440860004755944

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

Contacts#

Phone, Email table
PhoneEmail
+1 617 865 9401Info@InnoVoyce.com

Regulatory Flags#

DUNS number
118104468
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004755920InnoVoyce Laser FiberAASY-300063-3002023-12-01
00860004755937InnoVoyce Laser FiberAASY-300063-4002023-12-01
00860004755913InnoVoyce LLCAKLF-001-6002024-07-26
00860004755906InnoVoyce LLCAKLF-001-4002024-07-26
00860004755982InnoVoyce VYLO LaserAASY-3001342025-02-07
00860011812104InnoVoyce VYLO Eye Safety Filter ZeissAASY-3001442025-02-07
00860011812111InnoVoyce VYLO FootswitchAPRT-3010092025-02-07
00860011812180InnoVoyce VYLO CartALC-004552025-02-07
00860004755999InnoVoyce VYLO Eye Safety Filter LeicaAASY-3001432025-02-07
00860011812128InnoVoyce Laser FiberBI0128-ASY-300063-3002024-07-26
00860011812135InnoVoyce Laser FiberBI0128-ASY-300063-4002024-07-26
00860011812142InnoVoyce Laser FiberBI0128-ASY-300063-6002024-07-26
10860004755903InnoVoyce LLCAKLF-001-6002024-07-26
00860011812159InnoVoyce Laser FiberBI0128-ASY-300063-3002024-07-26
00860011812166InnoVoyce Laser FiberBI0128-ASY-300063-4002024-07-26
00860011812173InnoVoyce Laser FiberBI0128-ASY-300063-6002024-07-26
00860004755951InnoVoyce Laser FiberAASY-300063-3002023-12-01
00860004755968InnoVoyce Laser FiberAASY-300063-4002023-12-01
00860004755975InnoVoyce Laser FiberAASY-300063-6002023-12-01

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