FDA-Device2013-11-13Class II
MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
Insight Instruments, Inc.
Hazard
The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.
Sold states
Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.
Affected count
10212
Manufactured in
2580 Se Willoughby Blvd, N/A, Stuart, FL, United States
Products
MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0144-2014Don't want to check this manually?
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