FDA-Device2014-08-06Class II

PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma

Ra Medical Systems Inc
Hazard

RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed.

Sold states
Worldwide Distribution - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia.
Affected count
435 units
Manufactured in
1930 Kellogg Ave, Carlsbad, CA, United States
Products
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2123-2014

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