The following data is part of a premarket notification filed by Palomar Medical Products, Inc. with the FDA for Palomar Starlux Pulsed Light System.
| Device ID | K041086 |
| 510k Number | K041086 |
| Device Name: | PALOMAR STARLUX PULSED LIGHT SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PALOMAR MEDICAL PRODUCTS, INC. 131 KELEKENT LN. Cary, NC 27511 |
| Contact | Marcy Moore |
| Correspondent | Marcy Moore PALOMAR MEDICAL PRODUCTS, 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 | 2004-04-26 |
| Decision Date | 2005-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494108557 | K041086 | 000 |
| 00841494108007 | K041086 | 000 |
| 00841494107604 | K041086 | 000 |
| 00841494107574 | K041086 | 000 |
| 00841494107550 | K041086 | 000 |