Company ยท US
Ra Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2022. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 2022 | K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) Ra Medical Systems,Inc | PDU |
| Jul 27, 2021 | K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) Ra Medical Systems,Inc | PDU |
| May 24, 2017 | K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter Ra Medical Systems,Inc | PDU |
| Apr 3, 2007 | K062963 | PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 Ra Medical Systems,Inc | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2020 | Ra Medical Systems, Inc. DABRA Laser (RA-308 Excimer Laser)
Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomati Terminated |
PDU | K170349 |
| Jul 24, 2020 | Ra Medical Systems, Inc. DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease. Terminated |
PDU | K170349 |
| Jul 4, 2020 | Ra Medical Systems, Inc. DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to Terminated |
PDU | K170349 |
| Apr 1, 2020 | Ra Medical Systems, Inc. Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototh Terminated |
GEX | K062963 |
| Sep 19, 2019 | Ra Medical Systems, Inc. Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only
Revised Terminated |
PDU | K170349 |
| Feb 15, 2018 | Ra Medical Systems Inc The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them.
The system is a self-cont Terminated |
PDU | K170349 |
| Jul 28, 2014 | Ra Medical Systems Inc PHAROS Excimer Laser, Model No. EX-308
UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma Terminated |
GEX | K062963 |