The following data is part of a premarket notification filed by Palomar Medical Technologies, Inc. with the FDA for Palomar Lux1540 Handpiece.
| Device ID | K090195 |
| 510k Number | K090195 |
| Device Name: | PALOMAR LUX1540 HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PALOMAR MEDICAL TECHNOLOGIES, INC. 82 CAMBRIDGE ST. Burlington, MA 01803 |
| Contact | Sharon Timberlake |
| Correspondent | Sharon Timberlake PALOMAR MEDICAL TECHNOLOGIES, INC. 82 CAMBRIDGE ST. 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 | 2009-01-27 |
| Decision Date | 2009-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494100650 | K090195 | 000 |
| 00841494100247 | K090195 | 000 |