Devices

Device Recall PASCAL and PASCAL Streamline

Model / Serial
PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
Product Description
PASCAL and PASCAL Streamline (532 nm.577 nm); || Treats the patient's eye.
Manufacturer
Topcon Medical Laser Systems, Inc
1 Event
- Recall of Device Recall PASCAL and PASCAL Streamline

Manufacturer

Topcon Medical Laser Systems, Inc

Manufacturer Address
Topcon Medical Laser Systems, Inc, 3130 Coronado Dr, Santa Clara CA 95054-3205
Manufacturer Parent Company (2017)
Topcon Corporation
Source
USFDA

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