The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Shaser Hrs2 Hair Removal System.
| Device ID | K120080 |
| 510k Number | K120080 |
| Device Name: | SHASER HRS2 HAIR REMOVAL SYSTEM |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | SHASER, INC. 32 HARRISON ST. Melrose, MA 02176 |
| Contact | Glen Emelock |
| Correspondent | Glen Emelock SHASER, INC. 32 HARRISON ST. Melrose, MA 02176 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-11 |
| Decision Date | 2012-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10074590542971 | K120080 | 000 |
| 10074590533313 | K120080 | 000 |
| 10074590530404 | K120080 | 000 |
| 10074590512189 | K120080 | 000 |
| 10074590512172 | K120080 | 000 |