The following data is part of a premarket notification filed by Palomar Medical Technologies, Inc. with the FDA for Palomar Icon (tm) Aesthetic System.
| Device ID | K110907 |
| 510k Number | K110907 |
| Device Name: | PALOMAR ICON (TM) AESTHETIC SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-31 |
| Decision Date | 2011-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494107611 | K110907 | 000 |
| 00841494100261 | K110907 | 000 |
| 00841494100278 | K110907 | 000 |
| 00841494100285 | K110907 | 000 |
| 00841494100292 | K110907 | 000 |
| 00841494100308 | K110907 | 000 |
| 00841494100605 | K110907 | 000 |
| 00841494100674 | K110907 | 000 |
| 00841494100681 | K110907 | 000 |
| 00841494100698 | K110907 | 000 |
| 00841494100704 | K110907 | 000 |
| 00841494100711 | K110907 | 000 |
| 00841494106843 | K110907 | 000 |
| 00841494100117 | K110907 | 000 |