Integre Pro, Model L2RY
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081565 FDA 510(k)
- FDA Product Code
- HQF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Integre Pro, Model L2RY, is a Laser, Ophthalmic device designed for retinal photocoagulation and treatment of ocular conditions. It delivers controlled laser energy to the retina, aiding in the management of diabetic retinopathy, retinal tears, and other retinal pathologies by promoting tissue healing or sealing abnormal blood vessels.
This device is supplied as a reusable medical instrument, intended for use in clinical ophthalmology settings. It requires proper sterilisation and maintenance as per manufacturer guidelines, with no specific MRI safety restrictions noted. The device is authorised under FDA 510K and MDR compliance, adhering to regulatory standards for ophthalmic laser systems. Storage and handling must follow sterile instrument protocols to ensure safety and functionality.
Frequently asked questions
Is the Integre Pro, Model L2RY, a single-use or reusable device, and what maintenance is required?
The Integre Pro, Model L2RY, is designed as a reusable medical instrument for clinical ophthalmology settings. Since it is reusable, it must undergo proper sterilization and maintenance as outlined by the manufacturer to ensure safety and functionality. Sterile instrument protocols should be followed during storage and handling to prevent contamination or damage.
What types of retinal conditions is the Integre Pro, Model L2RY, intended to treat?
The Integre Pro, Model L2RY is specifically designed for retinal photocoagulation and the treatment of conditions such as diabetic retinopathy, retinal tears, and other retinal pathologies. It delivers controlled laser energy to promote tissue healing or seal abnormal blood vessels, aiding in the management of these conditions.
How should the Integre Pro, Model L2RY be stored, and are there any special handling instructions?
Since the Integre Pro, Model L2RY is a reusable device, it must be stored following sterile instrument protocols to maintain its integrity and safety. The manufacturer’s guidelines should be strictly adhered to for storage, handling, and sterilization to ensure proper functionality and compliance with regulatory standards.
Does the Integre Pro, Model L2RY have any restrictions regarding MRI compatibility?
The device documentation does not specify any MRI safety restrictions for the Integre Pro, Model L2RY. However, standard precautions for reusable medical instruments should still be followed, including proper sterilization and maintenance, to ensure safe use in clinical environments.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K081565 | Class II | Active |
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Manufacturer
- Manufacturer
- Ellex Medical Pty Ltd
- FDA Applicant
- Ellex Medical Pty, Ltd.
Sources (2)
- FDA 510(k) K081565 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026