The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Shaser Ipl Hair Removal System.
Device ID | K103560 |
510k Number | K103560 |
Device Name: | SHASER IPL HAIR REMOVAL SYSTEM |
Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
Applicant | SHASER, INC. 32 HARRISON ST. Melrose, MA 02176 |
Contact | Glen Emelock |
Correspondent | Glen Emelock SHASER, INC. 32 HARRISON ST. Melrose, MA 02176 |
Product Code | ONF |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-03 |
Decision Date | 2011-05-18 |
Summary: | summary |