FDA-Device2020-10-14Class II
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Ra Medical Systems, Inc.
Hazard
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, NC, NV, NY, OR, OK, PA, TX, WA and the country of Japan.
Affected count
54 units
Manufactured in
2070 Las Palmas Dr, N/A, Carlsbad, CA, United States
Products
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0050-2021Don't want to check this manually?
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