SUPRA 577Y

GUDID 03700542625316

577nm Ophthalmic Laser System used for Retinal Photocoagulation

QUANTEL MEDICAL

Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system

• Primary Device ID: 03700542625316
• NIH Device Record Key: ad8a7bd5-d79b-4303-aea7-32f8ddf5d192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPRA 577Y
• Version Model Number: SUPRA 577Y
• Company DUNS: 738574953
• Company Name: QUANTEL MEDICAL
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr
• Phone: +33(0)473745745
• Email: contact@quantel-medical.fr

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700542625316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091581

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-21
• Device Publish Date: 2016-09-23

Devices Manufactured by QUANTEL MEDICAL

• 03700542625569 - VITRA 2: 2022-01-06 The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissu
• 03700542625613 - VITRA 810: 2022-01-06 The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tis
• 03700542625927 - EASYRET: 2021-10-27 The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Zeiss mode) is a photocoagulator
• 03700542625132 - VITRA: 2021-04-21 Ophthalmic Laser Photocoagulator 532nm MonoSpot Laser Retinal Photocoagulation
• 03700542625286 - SUPRA: 2021-04-21 532nm Ophthalmic Laser System used for Retinal Photocoagulation
• 03700542625316 - SUPRA 577Y: 2021-04-21577nm Ophthalmic Laser System used for Retinal Photocoagulation
• 03700542625316 - SUPRA 577Y: 2021-04-21 577nm Ophthalmic Laser System used for Retinal Photocoagulation
• 03700542625415 - VITRA MULTISPOT: 2021-04-21 532nm Multispot Laser Retinal Photocoagulation
• 03700542625484 - EASYRET: 2021-04-21 577nm Fiber Technology Laser SingleSpot, MultiSpot and SubLiminal mode