The following data is part of a premarket notification filed by Integra Luxtec, Inc. with the FDA for Luxtec Mlx Light Source.
| Device ID | K081477 |
| 510k Number | K081477 |
| Device Name: | LUXTEC MLX LIGHT SOURCE |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | INTEGRA LUXTEC, INC. 99 HARTWELL ST. West Boylston, MA 01583 |
| Contact | Rita Wadleigh |
| Correspondent | Rita Wadleigh INTEGRA LUXTEC, INC. 99 HARTWELL ST. West Boylston, MA 01583 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-27 |
| Decision Date | 2008-06-18 |