FDA.reportPublic FDA data

Fraxis Duo Needle H/P

Primary DI
08800023200041
Brand
Fraxis Duo Needle H/P
Company
ILOODA.CO.,LTD
Model
FRX 2.0 Needle H/P
Device description
FRX 2.0 Needle H/P
Published
2016-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
OUHSkin Resurfacing Rf Applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
OUHSkin Resurfacing Rf ApplicatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160312000FRAXIS DUOIlooda Co,., Ltd.2016-10-28GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800023200041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800023200041088000232000418800023200041

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+821091905072charles.jeong@ilooda.com

Regulatory Flags#

DUNS number
631129749
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800023200942Secret DUO Main UnitSecret DUO2023-08-30
08800023200959Secret DUO Standard HandpieceSecret DUO2023-08-30
08800023201239Secret DUO Bigger HandpieceSecret DUO2023-08-30
08800023201390Secret DUO Laser HandpieceSecret DUO2023-08-30
08800023202168reepot Main UnitVSLS2023-08-30
08800023202175reepot HandpieceVSLS2023-08-30
08800023200966Secret DUOSecret DUO2022-10-27
08800023200218VIKINI Main UnitDET Main UnitDET Main Unit2018-01-15
08800023200225VIKINI Laser H/PDET Laser H/P2018-01-17
08800023200010Fraxis Duo Main UnitFRX 2.0 Main Unit2016-12-16
08800023200027Fraxis Duo ARMFRX 2.0 Articualed Arm2016-12-16
08800023200171Secret RF Main UnitMTR 2.0 Main Unit2017-08-11
08800023200188Secret RF Small H/PMTR 2.0 Small H/P2017-08-11
08800023200195Secret RF Bigger H/PMTR 2.0 Bigger H/P2017-08-11
08800023201444ACUTRONAcuTron2022-10-27
08800023201895ToRRMTX-C12022-10-27
08800023201376Secret RF SmartcureMTR 2.0 Smartcure2020-07-01
08800023202182reepotVSLS2022-10-27
08800023200898Fraxis 1.1 HandpieceFraxis 1.1 Handpiece2022-04-12
08800023200881Fraxis 1.1 Main UnitFraxis 1.1 Main Unit2022-04-05

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