The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Shaser Skin Beauty Intense Pulsed Light System Family For Acne.
| Device ID | K150282 |
| 510k Number | K150282 |
| Device Name: | Shaser Skin Beauty Intense Pulsed Light System Family For Acne |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | SHASER, INC. 10 MAGUIRE ROAD Lexington, MA 02421 |
| Contact | Anthony Burns |
| Correspondent | Anthony Burns SHASER, INC. 10 MAGUIRE ROAD 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 | 2015-02-05 |
| Decision Date | 2015-05-27 |
| Summary: | summary |