FDA.reportPublic FDA data

Gemini 810+980 Diode Laser Kit, International

Primary DI
00861407000389
Brand
Gemini 810+980 Diode Laser Kit, International
Company
AZENA MEDICAL, LLC
Model
8990
Published
2021-07-22
Public version status
New
Distribution status
Not 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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192617000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192617000Gemini 810+980 Soft Tissue LaserAzena Medical, LLC2020-02-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861407000389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861407000389008614070003898614070003890861407000389

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
Dry Heat Sterilization

Regulatory Flags#

DUNS number
073483242
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
00850010501079Gemini EVO91212022-02-04
00850010501086Gemini EVO91222022-02-04
00861407000303Gemini 810+980 Diode LaserEL-5-0012016-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
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08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16