The following data is part of a premarket notification filed by Palomar Medical Technologies, Inc. with the FDA for Primus Aesthetic Platform.
| Device ID | K103664 |
| 510k Number | K103664 |
| Device Name: | PRIMUS AESTHETIC PLATFORM |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | PALOMAR MEDICAL TECHNOLOGIES, INC. 15 Network Drive Burlington, MA 01803 |
| Contact | Sharon Timberlake |
| Correspondent | Sharon Timberlake PALOMAR MEDICAL TECHNOLOGIES, INC. 15 Network Drive Burlington, MA 01803 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-16 |
| Decision Date | 2011-03-17 |
| Summary: | summary |