The following data is part of a premarket notification filed by Palomar Medical Products, Inc. with the FDA for Loi System.
| Device ID | K090525 |
| 510k Number | K090525 |
| Device Name: | LOI SYSTEM |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | PALOMAR MEDICAL PRODUCTS, INC. 82 CAMBRIDGE ST. Burlington, MA 01803 |
| Contact | Sharon Timberlake |
| Correspondent | Sharon Timberlake PALOMAR MEDICAL PRODUCTS, INC. 82 CAMBRIDGE ST. Burlington, MA 01803 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-26 |
| Decision Date | 2009-06-01 |
| Summary: | summary |