The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Reddy Illuminator.
| Device ID | K950960 |
| 510k Number | K950960 |
| Device Name: | REDDY ILLUMINATOR |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | LUXTEC CORP. 326 CLARK ST. Worcester, MA 01606 -1214 |
| Contact | James W Hobbs |
| Correspondent | James W Hobbs LUXTEC CORP. 326 CLARK ST. Worcester, MA 01606 -1214 |
| Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-02 |
| Decision Date | 1995-09-08 |