Identity
- Trade Name
- PASCAL Synthesis TwinStar FDA UDI
- Generic Name
- Ophthalmic solid-state laser system, photodisruption FDA UDI
- Device Name
- PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III (PACKED) FDA UDI
- Model / Reference
- PASCAL Synthesis 577 /638 FDA UDI
- Description
- PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III (PACKED) FDA UDI
Identifiers
- Catalog Number
- SA-06288 FDA UDI
- Primary DI / UDI-DI
- 00855005006188 FDA UDI
- 510(k) Number
- K170409 FDA UDI
- FDA Product Code
- GEX FDA UDIHQF FDA UDI
- GMDN Term
- Ophthalmic solid-state laser system, photodisruption FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI886.4390 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
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 TwinStar 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
K170409 also covers:
- PASCAL Synthesis TwinStar (577nm/638nm) — Iridex Corporation
- PASCAL Synthesis TwinStar (577nm/638nm) — Iridex Corporation
- PASCAL Synthesis TwinStar — Topcon Medical Laser Systems, Inc.
- PASCAL Synthesis TwinStar — Topcon Medical Laser Systems, Inc.
- PASCAL Synthesis TwinStar — Topcon Medical Laser Systems, Inc.
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 baa00a6e-fdd5-4880-aa03-6e5b4bfb4b48 37 fields · synced May 30, 2026