The following data is part of a premarket notification filed by Radiancy (israel) Ltd. with the FDA for Spr System.
| Device ID | K033181 |
| 510k Number | K033181 |
| Device Name: | SPR SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RADIANCY (ISRAEL) LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan RADIANCY (ISRAEL) LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-01 |
| Decision Date | 2003-10-24 |
| Summary: | summary |