The following data is part of a premarket notification filed by Palomar Medical Technologies, Inc. with the FDA for Artisan Aesthetic System.
| Device ID | K100270 |
| 510k Number | K100270 |
| Device Name: | ARTISAN AESTHETIC SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PALOMAR MEDICAL TECHNOLOGIES, INC. 15 Network Drive Burlington, MA 01803 |
| Contact | Sharon Timberlake, Mshs, Rac, Cc |
| Correspondent | Sharon Timberlake, Mshs, Rac, Cc 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 | 2010-01-29 |
| Decision Date | 2010-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494108380 | K100270 | 000 |
| 00841494108373 | K100270 | 000 |
| 00841494108045 | K100270 | 000 |