The following data is part of a premarket notification filed by Palomar Medical Technologies, Inc. with the FDA for Palomar Luxv Handpiece.
| Device ID | K040081 |
| 510k Number | K040081 |
| Device Name: | PALOMAR LUXV HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PALOMAR MEDICAL TECHNOLOGIES, INC. 131 KELEKENT LN. Cary, NC 27511 |
| Contact | Marcy Moore |
| Correspondent | Marcy Moore PALOMAR MEDICAL TECHNOLOGIES, INC. 131 KELEKENT LN. Cary, NC 27511 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-15 |
| Decision Date | 2004-04-01 |
| Summary: | summary |