SKINSTATION
Powered Laser Surgical Instrument
RADIANCY (ISRAEL) LTD.
The following data is part of a premarket notification filed by Radiancy (israel) Ltd. with the FDA for Skinstation.
Pre-market Notification Details
| Device ID | K030897 |
| 510k Number | K030897 |
| Device Name: | SKINSTATION |
| 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 | 2003-03-21 |
| Decision Date | 2003-06-19 |
| Summary: | summary |
Trademark Results [SKINSTATION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SKINSTATION 78173708 2753213 Live/Registered |
Radiancy Inc. 2002-10-11 |
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