The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Shaser V-mini Hair Removal System.
Device ID | K130015 |
510k Number | K130015 |
Device Name: | SHASER V-MINI HAIR REMOVAL SYSTEM |
Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
Applicant | SHASER, INC. 10 MAGUIRE RD STE 120 BUILDING ONE Lexington, MA 02421 |
Contact | Sarah Hackett |
Correspondent | Sarah Hackett SHASER, INC. 10 MAGUIRE RD STE 120 BUILDING ONE Lexington, MA 02421 |
Product Code | ONF |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-03 |
Decision Date | 2013-06-13 |
Summary: | summary |