The following data is part of a premarket notification filed by Dusa Pharmaceuticals, Inc. with the FDA for Panalight-blu, Model 4175.
| Device ID | K043164 |
| 510k Number | K043164 |
| Device Name: | PANALIGHT-BLU, MODEL 4175 |
| 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 | 2004-11-16 |
| Decision Date | 2004-12-10 |
| Summary: | summary |