FDA.reportPublic FDA data

QuRAS Collimation H/P

Primary DI
08800023200270
Brand
QuRAS Collimation H/P
Company
ILOODA.CO.,LTD
Model
QND Collimation H/P
Device description
QND Collimation H/P
Published
2018-01-16
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173038000CuRAS Nd:YAG LaserIlooda Co,., Ltd.2017-12-01GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800023200270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800023200270088000232002708800023200270

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological frequency-doubled 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 to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm); it may include additional glass/crystal rods and pumping options to achieve additional laser wavelengths. It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes.

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
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
08800023201376Secret RF SmartcureMTR 2.0 Smartcure2020-07-01
08800023202182reepotVSLS2022-10-27
08800023200898Fraxis 1.1 HandpieceFraxis 1.1 Handpiece2022-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
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
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16