Recall Z-2123-2014— Ra Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Ra Medical Systems Inc, initiated 2014-06-30, terminated 2014-09-09. It names one FDA 510(k) clearance: K062963. Product: PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma. Reason: 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..
- Recalling firm
- Ra Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-30
- Terminated
- 2014-09-09
- Firm location
- Carlsbad, CA, 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
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.