The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Shaser Hrs2 Rx Hair Removal System.
| Device ID | K132266 |
| 510k Number | K132266 |
| Device Name: | SHASER HRS2 RX 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 | Anthony Burns |
| Correspondent | Anthony Burns 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 | 2013-07-22 |
| Decision Date | 2013-09-30 |
| Summary: | summary |