Integre Pro Scan Red-Green LP6RG
Integre Pro Scan Red-Green LP6RG is a Class II device made by Ellex Medical Pty Ltd, cleared under FDA 510(k) K142398 on 14 Jul 2015 and listed in FDA GUDID since 2 Mar 2016 (UDI-DI 09342395000144), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09342395000144 | Date2 Mar 2016 | StatusListed |
| United States | FDA 510(k) | NumberK142398 | Date14 Jul 2015 | StatusActive |
Official records
- AccessGUDID record 09342395000144
- FDA 510(k) database K142398
Across registries
- FDA 510(k) K142398 decided 14 Jul 2015 Active
- FDA GUDID UDI-DI 09342395000144 listed 2 Mar 2016 Listed
Recalls
-
- Ongoing Z-1971-2023
When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.
Timeline
- Cleared FDA 510(k) K142398
- Listed FDA GUDID 09342395000144
- Recall initiated FDA recalls Z-1971-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Integre Pro Scan Red-Green
- Generic name
- Ophthalmic solid-state laser system
- Model / reference
- LP6RG
- Primary DI / UDI-DI
- 09342395000144
- 510(k) Number
- FDA product code
- HQF
- GMDN term
- Ophthalmic solid-state laser system
- Device class
- Class II
- Regulation number
- 886.4390
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ophthalmic solid-state laser system.