SUPRA 577Y

Basic Information

• Brand Name: SUPRA 577Y
• Primary DI: 03700542625316
• Version / Model: SUPRA 577Y
• Company Name: QUANTEL MEDICAL
• Labeler DUNS: 738574953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: ad8a7bd5-d79b-4303-aea7-32f8ddf5d192

Device Description

577nm Ophthalmic Laser System used for Retinal Photocoagulation

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQF	Laser, Ophthalmic	Ophthalmic	886.4390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62161	Ophthalmic diode laser system	An electrically-powered device assembly in which input energy is used to excite a diode to emit a low-power and/or high-power therapeutic laser beam intended for ophthalmic surgery (e.g., ocular incisions, ocular photocoagulation, iridectomy, vitrectomy). Some types may also include an air pump to disperse subretinal fluid in certain procedures (e.g. retinal detachment repair). The laser utilizes a diode/semiconductor chip (as the active medium); it does not include femtosecond pulsing, or fundus imaging technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700542625316	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K091581	000