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 |