Twain Evo

GUDID 08033945935009

Intense Pulsed Light handpiece (Removable waveguide)

QUANTA SYSTEM SPA

Light-energy skin surface treatment system applicator
Primary Device ID08033945935009
NIH Device Record Key6a4f9104-bd25-422f-9f7e-54d873d8907b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwain Evo
Version Model NumberOAM001815
Company DUNS436045833
Company NameQUANTA SYSTEM SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033945935009 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-09
Device Publish Date2016-08-29

On-Brand Devices [Twain Evo]

08033945935177Intense Pulsed Light handpiece 650 nm 48x13 (cooled)
08033945935160Intense Pulsed Light handpiece 625 nm 48x13 (cooled)
08033945935146Intense Pulsed Light handpiece 570 nm 48x13 (cooled)
08033945935139Intense Pulsed Light handpiece 550 nm 48x13 (cooled)
08033945935122Intense Pulsed Light handpiece 400 nm 48x13 (cooled)
08033945935115Intense Pulsed Light handpiece 650 nm 48x13
08033945935108Intense Pulsed Light handpiece 625 nm 25x13
08033945935085Intense Pulsed Light handpiece 590 nm 25x13
08033945935061Intense Pulsed Light handpiece 570 nm 25x13
08033945935054Intense Pulsed Light handpiece 570 nm 48x13
08033945935030Intense Pulsed Light handpiece 550 nm 48x13
08033945935023Intense Pulsed Light handpiece 400 nm 25x13
08033945935016Intense Pulsed Light handpiece 400 nm 48x13
08033945935009Intense Pulsed Light handpiece (Removable waveguide)
08059173391844Intense Pulsed Light handpiece 570 nm 48x13 (cooled)
08059173391837Intense Pulsed Light handpiece 550 nm 48x13 (cooled)
08059173391820Intense Pulsed Light handpiece 400 nm 48x13 (cooled)

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