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PASCAL Synthesis

FDA UDI

Class II (US FDA UDI)

by Topcon Medical Laser Systems, Inc.

Identity

Trade Name
PASCAL Synthesis FDA UDI
Generic Name
Ophthalmic solid-state laser system, photodisruption FDA UDI
Device Name
(577) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE FDA UDI
Model / Reference
PASCAL Synthesis 577 FDA UDI
Description
(577) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE FDA UDI

Identifiers

Catalog Number
SA-06285 FDA UDI
Primary DI / UDI-DI
00855005006034 FDA UDI
510(k) Number
K123542 FDA UDI
FDA Product Code
GEX FDA UDI
HQF FDA UDI
GMDN Term
Ophthalmic solid-state laser system, photodisruption FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
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: 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.

Cleared under the same submission

K123542 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Topcon Medical Laser Systems, Inc.

Sources (1)

  • FDA UDI 0513d803-608d-4dce-9037-1d9fc88fad2b 37 fields · synced May 30, 2026