Easyret
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- EASYRET EUDAMED
- Device Name
- EASYRET EUDAMED
- Model / Reference
- PABX0041ZEDI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700542626269 EUDAMED
- Basic UDI-DI
- B-03700542626269 EUDAMED
- 510(k) Number
- K170067 FDA 510(k)
- FDA Product Code
- HQF FDA 510(k)
- EMDN Code
- Z12011011 KTP SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Market of Registration
- Czechia EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Easyret Laser System is an ophthalmic laser device designed for retinal photocoagulation procedures. It delivers precise laser energy to treat retinal conditions such as diabetic retinopathy, retinal vein occlusion, and macular edema by inducing controlled tissue changes to preserve vision.
This device is intended for use in clinical settings by trained ophthalmologists or laser specialists. Supplied as a reusable medical instrument, it requires adherence to standard sterilization protocols between uses. The system is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD authorization. Multiple model and reference codes are associated with its regulatory submissions, ensuring compliance with international standards for ophthalmic laser safety and performance.
Frequently asked questions
What types of retinal conditions is the Easyret Laser System specifically designed to treat, and how does it work?
The Easyret Laser System is designed to treat retinal conditions such as diabetic retinopathy, retinal vein occlusion, and macular edema. It delivers precise laser energy to induce controlled tissue changes, helping to preserve vision by targeting affected areas in the retina. The system is intended for use by trained ophthalmologists or laser specialists in clinical settings.
Is the Easyret Laser System reusable, and what sterilization protocols should be followed between uses?
Yes, the Easyret Laser System is supplied as a reusable medical instrument. Between uses, it must adhere to standard sterilization protocols to ensure safety and prevent cross-contamination. Proper sterilization is critical for maintaining device integrity and compliance with clinical standards.
How do I confirm the regulatory compliance of the Easyret Laser System for use in my country?
The Easyret Laser System holds FDA 510(k) clearance and MDD authorization, indicating compliance with U.S. and European regulatory standards. For specific country requirements, verify local regulations or consult Quantel Medical’s documentation, as additional approvals may be needed depending on regional health authorities.
What is the classification of the Easyret Laser System under FDA regulations, and what does this mean for its use?
The Easyret Laser System is classified as a Class II medical device under FDA regulations. This classification means it is subject to special controls to ensure its safety and effectiveness, including performance standards and post-market surveillance, while still allowing for broader availability than Class III devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170067 | Class II | Active |
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Manufacturer
- Manufacturer
- Quantel Medical
Sources (2)
- FDA 510(k) K170067 24 fields · synced Sep 18, 2026
- EUDAMED d5aa343f-5709-4595-97df-d7a2fd07c940 61 fields · synced Jul 11, 2026