The following data is part of a premarket notification filed by Aculux with the FDA for Aculux, Model Ax3001, Ax3002.
| Device ID | K001223 |
| 510k Number | K001223 |
| Device Name: | ACULUX, MODEL AX3001, AX3002 |
| Classification | Lamp, Operating-room |
| Applicant | ACULUX 273 SOUTH AIRPORT PULLING RD. Naples, FL 34104 |
| Contact | Kim Marsh |
| Correspondent | Kim Marsh ACULUX 273 SOUTH AIRPORT PULLING RD. Naples, FL 34104 |
| Product Code | FQP |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-17 |
| Decision Date | 2000-06-23 |