577nm Heine Omega 500 IO with integrated adaptor

GUDID 03700542625392

577nm Heine Omega 500 Indirect Ophthalmoscope with integrated adaptor

QUANTEL MEDICAL

Indirect binocular laser ophthalmoscope

• Primary Device ID: 03700542625392
• NIH Device Record Key: 3f0f2079-892e-4a49-9692-9b34e0070152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 577nm Heine Omega 500 IO with integrated adaptor
• Version Model Number: IOH577
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700542625392 [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: 2021-02-19
• Device Publish Date: 2016-09-23

Devices Manufactured by QUANTEL MEDICAL

• 03700542625958 - CAPSULO: 2025-04-02 Capsulo is indicated for photodisruption of ocular tissue using light energy emitted by a Nd. Yag laser, including discission of
• 03700542626009 - POCKET III: 2025-04-02 The POCKET III unit is an ultrasonic pachymeter intended to be used for the measurement of corneal thickness by ultrasonic means
• 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: 2021-04-21 577nm Ophthalmic Laser System used for Retinal Photocoagulation