The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Shaser V-mini 2 Hair Removal System.
Device ID | K133201 |
510k Number | K133201 |
Device Name: | SHASER V-MINI 2 HAIR REMOVAL SYSTEM |
Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
Applicant | SHASER, INC. 10 MAGUIRE RD BUILDING ONE Lexington, MA 02421 |
Contact | Anthony Burns |
Correspondent | Anthony Burns SHASER, INC. 10 MAGUIRE RD 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 | 2013-10-17 |
Decision Date | 2014-02-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10074590542926 | K133201 | 000 |
10074590546030 | K133201 | 000 |
10074590535478 | K133201 | 000 |