Devices

Device Recall Fraxel Laser System

Model / Serial
Model MC-SYS-SR1500-D, Revisions A and B.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution
Product Description
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Manufacturer
Solta Medical, Inc.
1 Event
- Recall of Device Recall Fraxel 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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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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