Ra Medical Systems Inc

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
4
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0569-2021Class IIDABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripOctober 16, 2020
Z-0050-2021Class IIDABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating July 24, 2020
Z-2497-2020Class IIDABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolJanuary 23, 2020
Z-2006-2020Class IIRa Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09September 19, 2019
Z-1631-2020Class IIPharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is desigAugust 23, 2019
Z-2218-2019Class IIThe DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly througFebruary 15, 2018
Z-2123-2014Class IIPHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo,June 30, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)June 29, 2022
K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)July 27, 2021
K170349RA-308 Excimer Laser System, Excimer Laser CatheterMay 24, 2017
K062963PHAROS EXCIMER LASER SYSTEM, MODEL EX-308April 3, 2007