FDA-Device2013-12-18Class II
Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
Trumpf Medical Systems, Inc.
Hazard
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Sold states
US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
Affected count
287
Manufactured in
415 Jessen Ln, Charleston, SC, United States
Products
Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0484-2014Don't want to check this manually?
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