Recall Z-2191-2013— Lumenis, Inc.
Class II · Terminated
Class II FDA medical device recall by Lumenis, Inc., initiated 2013-08-19, terminated 2013-12-19. It names one FDA 510(k) clearance: K111213. Product: Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.. Reason: Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user..
- Recalling firm
- Lumenis, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-19
- Terminated
- 2013-12-19
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Reason for recall
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
Data sourced from openFDA. This site is unofficial and independent of the FDA.