Identity
- Trade Name
- PASCAL Synthesis FDA UDI
- Generic Name
- Ophthalmic solid-state laser system, photodisruption FDA UDI
- Device Name
- PASCAL Synthesis SLC & ESF (532 nm) for BQ B1 RELEASE FDA UDI
- Model / Reference
- Synthesis SLC & ESF 532 FDA UDI
- Description
- PASCAL Synthesis SLC & ESF (532 nm) for BQ B1 RELEASE FDA UDI
Identifiers
- Catalog Number
- SA-06194 FDA UDI
- Primary DI / UDI-DI
- 00855005006089 FDA UDI
- 510(k) Number
- K123542 FDA UDI
- FDA Product Code
- HQF FDA UDIGEX FDA UDI
- GMDN Term
- Ophthalmic solid-state laser system, photodisruption 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, photodisruption
PASCAL Synthesis by Topcon Medical Laser Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic solid-state laser system, photodisruption.
- OPTIMIS FUSION — QUANTEL MEDICAL · Class II
- VISULAS YAG III — Carl Zeiss Meditec AG · Class II
- PASCAL Synthesis, 532nm — Iridex Corporation · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- OPTIMIS II — QUANTEL MEDICAL · Class II
- Ellex — ELLEX MEDICAL PTY LTD · Class II
- PASCAL Synthesis, 532nm — Iridex Corporation · Class II
- YAG laser combination delivery unit (YC-200) — Nidek, Inc. · Class II
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 |
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Manufacturer
- Manufacturer
- Topcon Medical Laser Systems, Inc.
Sources (1)
- FDA UDI ccc820a3-4497-4350-ab4c-116e453e9577 37 fields · synced Jun 8, 2026