Twain Evo

GUDID 08059173391820

Intense Pulsed Light handpiece 400 nm 48x13 (cooled)

QUANTA SYSTEM SPA

Light-energy skin surface treatment system applicator

• Primary Device ID: 08059173391820
• NIH Device Record Key: c5318d2c-4761-4dfc-a933-67b56cee71ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twain Evo
• Version Model Number: OAM001828.01
• Company DUNS: 436045833
• Company Name: QUANTA SYSTEM SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08059173391820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192160

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-13
• Device Publish Date: 2021-10-05

On-Brand Devices [Twain Evo]

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