DEVICE: PASCAL Synthesis (00855005006034)

Download: XML | JSON

Device Identifier (DI) Information

PASCAL Synthesis
PASCAL Synthesis 577
SA-06285
Topcon Medical Laser Systems, Inc.
00855005006034
GS1
1
(577) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ophthalmic solid-state laser system, photodisruption A mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended to cause a photodisruptive effect in the eye by forming a plasma and generating mechanical shock waves (microexplosions) that destroy tissue when highly focused (e.g., for cataract extraction, posterior capsulotomy). It typically includes a light source and controls/foot-switch and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors. It does not include femtosecond pulsing, frequency doubling, or fundus imaging technology.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEX Powered laser surgical instrument
HQF Laser, ophthalmic
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 55 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
April 15, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(888)850-1223
tmlsservice@topcon.com
CLOSE