The following data is part of a premarket notification filed by Radiancy (israel) Ltd. with the FDA for Radiancy Mistral Device.
| Device ID | K072331 |
| 510k Number | K072331 |
| Device Name: | RADIANCY MISTRAL DEVICE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RADIANCY (ISRAEL) LTD. 990 WASHINGTON ST. Dedham, MA 02026 |
| Contact | Zvi Ladin |
| Correspondent | Zvi Ladin RADIANCY (ISRAEL) LTD. 990 WASHINGTON ST. Dedham, MA 02026 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-20 |
| Decision Date | 2008-01-07 |
| Summary: | summary |