FDA.reportPublic FDA data

Secret RF Smartcure

Primary DI
08800023201376
Brand
Secret RF Smartcure
Company
ILOODA.CO.,LTD
Model
MTR 2.0 Smartcure
Device description
MTR 2.0 Smartcure
Published
2020-07-01
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
K182355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182355000Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.2019-09-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800023201376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800023201376088000232013768800023201376

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82312101663sakura3037@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
08800023200041Fraxis Duo Needle H/PFRX 2.0 Needle H/P2016-12-16
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
08800023202182reepotVSLS2022-10-27
08800023200898Fraxis 1.1 HandpieceFraxis 1.1 Handpiece2022-04-12
08800023200881Fraxis 1.1 Main UnitFraxis 1.1 Main Unit2022-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006051Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006068Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006129Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006136Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006143Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006150Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006167Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006174Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006181Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006198Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006204Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006211Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006228Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006235Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006242Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006266Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006273Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006310Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006341Triple Footswitch & CableELLIQUENCE, LLCGEI2026-06-02
00846338007133Trigger-Flex Quad Pro Bipolar SystemELLIQUENCE, LLCGEI2026-06-02
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-02
00846338004712Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004729Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004736Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01