The following data is part of a premarket notification filed by Palomar Medical Products, Inc. with the FDA for Epilaser I Upgrade Kit.
| Device ID | K980160 |
| 510k Number | K980160 |
| Device Name: | EPILASER I UPGRADE KIT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PALOMAR MEDICAL PRODUCTS, INC. 45 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Anthony Fiorillo |
| Correspondent | Anthony Fiorillo PALOMAR MEDICAL PRODUCTS, INC. 45 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-03-10 |
| Summary: | summary |