The following data is part of a premarket notification filed by Ra Medical Systems, Inc. with the FDA for Pharos Excimer Laser System, Model Ex-308.
| Device ID | K062963 |
| 510k Number | K062963 |
| Device Name: | PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RA MEDICAL SYSTEMS, INC. 2270 CAMINO VIDA ROBLE SUITE L Carlsbad, CA 92011 |
| Contact | Dean Irwin |
| Correspondent | Dean Irwin RA MEDICAL SYSTEMS, INC. 2270 CAMINO VIDA ROBLE SUITE L Carlsbad, CA 92011 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2007-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842362100017 | K062963 | 000 |