Identity
- Trade Name
- PASCAL Laser Indirect Ophthalmoscope FDA UDI
- Generic Name
- Indirect binocular laser ophthalmoscope FDA UDI
- Device Name
- KIT, PASCAL LIO, 532 nm PASCAL SYNTHESIS D RELEASE FDA UDI
- Model / Reference
- LIO for Synthesis 532 FDA UDI
- Description
- KIT, PASCAL LIO, 532 nm PASCAL SYNTHESIS D RELEASE FDA UDI
Identifiers
- Catalog Number
- SA-06171 FDA UDI
- Primary DI / UDI-DI
- 00855005006126 FDA UDI
- 510(k) Number
- K123056 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Indirect binocular laser ophthalmoscope 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
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: Indirect binocular laser ophthalmoscope
PASCAL Laser Indirect Ophthalmoscope by Topcon Medical Laser Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indirect binocular laser ophthalmoscope.
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- 532nm Heine Omega IO with integrated adaptor — QUANTEL MEDICAL · Class II
- Ellex — ELLEX MEDICAL PTY LTD · Class II
- TruFocus LIO Premiere — Iridex Corporation · Class II
- Ellex — ELLEX MEDICAL PTY LTD · Class II
- Norlase LION photocoagulator — Norlase Aps · Class II
Cleared under the same submission
K123056 also covers:
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 ceff1841-0237-4a80-9a7c-0f4c713e214d 37 fields · synced May 30, 2026