The following data is part of a premarket notification filed by General Project S.r.l. with the FDA for Axiom Pulsed Light System.
| Device ID | K062312 |
| 510k Number | K062312 |
| Device Name: | AXIOM PULSED LIGHT SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GENERAL PROJECT S.R.L. 56 WESTCOTT ROAD Stamford, CT 06902 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky GENERAL PROJECT S.R.L. 56 WESTCOTT ROAD Stamford, CT 06902 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-08 |
| Decision Date | 2006-10-16 |
| Summary: | summary |