Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo LP1RG-S, LP1RG-D
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K052777 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Laserex Duo family of dual wavelength ophthalmic lasers are devices used for photocoagulation of anterior and posterior eye segments. These lasers are intended for use in the treatment of ocular pathology by ophthalmologists in clinical settings.
The Laserex Duo family includes models Integre Duo LP1RG-S and LP1RG-D. The device is authorized under FDA 510K clearance with product code GEX. It is supplied for use in clinical settings for photocoagulation procedures of both anterior and posterior segments of the eye.
Frequently asked questions
What is the LASEREX DUO family of lasers used for?
The LASEREX DUO family of dual wavelength ophthalmic lasers are devices used for photocoagulation of anterior and posterior eye segments. They are intended for use in the treatment of ocular pathology by ophthalmologists in clinical settings.
What models are included in the LASEREX DUO family?
The LASEREX DUO family includes models Integre Duo LP1RG-S and LP1RG-D. Both models are designed for photocoagulation procedures of both anterior and posterior segments of the eye in clinical settings.
What is the regulatory status of the LASEREX DUO lasers?
The LASEREX DUO family of lasers is authorized under FDA 510K clearance with product code GEX. The device received FDA clearance on March 16, 2006, with decision code SESE indicating substantial equivalence.
How are the LASEREX DUO lasers supplied?
The LASEREX DUO lasers are supplied for use in clinical settings for photocoagulation procedures. The devices are manufactured by Ellex Medical Pty Ltd and are intended for use by ophthalmologists in treating ocular pathology.
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. Sources consulted: Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including ..., PDF .' DEPARTMENT OF HEALTH & HUMAN SERVICES Public, Ellex - Lumibird Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052777 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ellex Medical Pty Ltd
- FDA Applicant
- Ellex Medical Pty, Ltd.
Sources (1)
- FDA 510(k) K052777 24 fields · synced Oct 6, 2026