Identity
- Trade Name
- PASCAL Synthesis, 577nm FDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- PASCAL Synthesis SLC & ESF (577nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher - IRIDEX FDA UDI
- Model / Reference
- Synthesis SLC & ESF 577 FDA UDI
- Description
- PASCAL Synthesis SLC & ESF (577nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher - IRIDEX FDA UDI
Identifiers
- Catalog Number
- SA-06377 FDA UDI
- Primary DI / UDI-DI
- 00813125016715 FDA UDI
- 510(k) Number
- K123542 FDA UDI
- FDA Product Code
- HQF FDA UDIGEX FDA UDI
- GMDN Term
- Ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 FDA UDI878.4810 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
Yes
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
PASCAL Synthesis, 577nm by Iridex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123542 also covers:
- PASCAL Synthesis, 532nm — Iridex Corporation
- PASCAL Synthesis, 532nm — Iridex Corporation
- PASCAL Synthesis, 532nm — Iridex Corporation
- PASCAL Synthesis, 532nm — Iridex Corporation
- PASCAL Synthesis, 532nm — Iridex Corporation
- PASCAL Synthesis, 532nm — Iridex Corporation
- PASCAL Synthesis, 532nm — Iridex Corporation
- PASCAL Synthesis, 577nm — Iridex Corporation
- PASCAL Synthesis, 577nm — Iridex Corporation
- PASCAL Synthesis, 577nm — Iridex Corporation
- PASCAL Synthesis, 577nm — Iridex Corporation
- PASCAL Synthesis, 577nm — Iridex Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Iridex Corporation
Sources (1)
- FDA UDI 39dc2ca2-83fd-454f-bf53-062a7d0ed338 37 fields · synced Jun 9, 2026