FDA.reportPublic FDA data

Gemini EVO

Primary DI
00850010501079
Brand
Gemini EVO
Company
AZENA MEDICAL, LLC
Model
9121
Device description
Gemini EVO International Laser
Published
2022-02-04
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
ILYLamp, Infrared, Therapeutic Heating
NVKLaser, Dental, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
NVKLaser, Dental, Soft TissueGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210350000Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC2021-11-18NVK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010501079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010501079008500105010798500105010790850010501079

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
073483242
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861407000310Gemini8983EL-5-0052023-11-03
00861407000327Gemini8984EL-5-0062023-11-03
00861407000334Gemini8985El-5-0022023-11-03
00850010501093Gemini EVO9123G2-5-0072022-05-13
00850010501109Gemini EVO9124G2-5-0082022-05-13
00850010501116Gemini EVO9125G2-5-0042022-05-13
00850010501123Gemini EVO9126G2-5-0052022-05-13
00850010501130GEMINI EVO9127G2-5-0062022-05-13
00850010501062Gemini EVO91202022-02-04
00850010501086Gemini EVO91222022-02-04
00861407000389Gemini 810+980 Diode Laser Kit, International89902021-07-22
00861407000303Gemini 810+980 Diode LaserEL-5-0012016-09-01

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