The following data is part of a premarket notification filed by Zila, Inc. with the FDA for Vizilite Eyewear.
| Device ID | K080043 |
| 510k Number | K080043 |
| Device Name: | VIZILITE EYEWEAR |
| Classification | Diagnostic Light, Soft Tissue Detector |
| Applicant | ZILA, INC. 5227 N. 7TH ST. Phoenix, AZ 85014 |
| Contact | Mark Bride |
| Correspondent | Mark Bride ZILA, INC. 5227 N. 7TH ST. Phoenix, AZ 85014 |
| Product Code | NXV |
| CFR Regulation Number | 872.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-08 |
| Decision Date | 2008-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8136501010 | K080043 | 000 |