Devices

Device Recall Fraxel re:store Dual Laser System

Model / Serial
Serial Numbers: F1196J, J0007, J0010-J0058, J0060-J0203, J0205, J0207-J0209, J0211-J0337, J0339-J0359, J0361-J0414, J0417-J0419, J0426
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA and countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Egypt, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Kuwait, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Poland, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam
Product Description
Fraxel re:store¿ Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. || Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA || The Fraxel re:store¿ Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
Manufacturer
Solta Medical, Inc.
1 Event
- Recall of Device Recall Fraxel re:store Dual Laser System

Manufacturer

Solta Medical, Inc.

Manufacturer Address
Solta Medical, Inc., 25881 Industrial Blvd, Hayward CA 94545-2991
Manufacturer Parent Company (2017)
Bausch Health Cos., Inc.
Source
USFDA

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