The following data is part of a premarket notification filed by Radiancy (israel) Ltd. with the FDA for Spatouch Photoepilation System.
Device ID | K020856 |
510k Number | K020856 |
Device Name: | SPATOUCH PHOTOEPILATION 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 | 2002-03-15 |
Decision Date | 2002-06-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPATOUCH PHOTOEPILATION SYSTEM 75920410 2721800 Dead/Cancelled |
RADIANCY INC. 2000-02-06 |