The following data is part of a premarket notification filed by Aculux, Inc. with the FDA for Xenalight Models # Ax9125 (100-120v~); # Ax9225 (220-240v~).
| Device ID | K013511 |
| 510k Number | K013511 |
| Device Name: | XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) |
| Classification | Light, Surgical, Endoscopic |
| Applicant | ACULUX, INC. 273 SOUTH AIRPORT PULLING RD. Naples, FL 34104 |
| Contact | Kim Marsh |
| Correspondent | Kim Marsh ACULUX, INC. 273 SOUTH AIRPORT PULLING RD. Naples, FL 34104 |
| Product Code | FSW |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2002-02-01 |