PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
FDA 510(k) clearance K062963 · decided 2007-04-03
Clearance details
- K-number
- K062963
- Device name
- PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
- Applicant
- Ra Medical Systems,Inc
- Decision
- Substantially Equivalent
- Date received
- 2006-09-29
- Decision date
- 2007-04-03
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser Syste recall (Z-1631-2020) | Ra Medical Systems, Inc. | 2020-04-01 |
| PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vi recall (Z-2123-2014) | Ra Medical Systems Inc | 2014-07-28 |