The following data is part of a premarket notification filed by Dusa Pharmaceuticals, Inc. with the FDA for Blu-u, Model 4170.
| Device ID | K031805 |
| 510k Number | K031805 |
| Device Name: | BLU-U, MODEL 4170 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DUSA PHARMACEUTICALS, INC. 25 UPTON DR. Wilmington, MA 01887 |
| Contact | Scott Lundahl |
| Correspondent | Scott Lundahl DUSA PHARMACEUTICALS, INC. 25 UPTON DR. Wilmington, MA 01887 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-11 |
| Decision Date | 2003-09-09 |
| Summary: | summary |