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Integre Pro Scan Green-Yellow
FDA UDIFDA 510(k)EUDAMEDClass II (US FDA UDI)
510(k) K142398
Identity
- Trade Name
- Integre Pro Scan Green-Yellow FDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Model / Reference
- LP6GY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09342395000267 FDA UDI
- 510(k) Number
- K142398 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic solid-state laser system
Integre Pro Scan Green-Yellow by Ellex Medical Pty Ltd — Class II — FDA_510K, MDD, MDR — listed in FDA GUDID, FDA 510(k), EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
MDD
European Union Unknown
MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142398 | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
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Manufacturer
- Manufacturer
- Ellex Medical Pty Ltd
- FDA Applicant
- Ellex Medical Pty, Ltd.
Sources (3)
- FDA UDI d5846390-e02e-4fba-8909-d15bf5a35a9b 57 fields · synced Jun 19, 2026
- FDA 510(k) K142398 1 fields · synced Jun 4, 2026
- EUDAMED 1 fields · synced Jun 2, 2026