VIZILITE EYEWEAR
FDA 510(k) clearance K080043 · decided 2008-04-04
Clearance details
- K-number
- K080043
- Device name
- VIZILITE EYEWEAR
- Applicant
- Zila, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-08
- Decision date
- 2008-04-04
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- NXV
- Device class
- 2
- Regulation number
- 872.6350
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| G.o.c.c.l.e.s. (K151630) | Pierrel Pharma S.R.L. | 2015-09-15 |
| ORALID (K123169) | Forward Science, LLC | 2013-03-13 |
| MICROLUX/DL MICROLUX/BLU BIO/SCREEN (K121282) | Addent, Inc. | 2012-07-24 |
| VELSCOPE VX (K102083) | Led Dental, Inc. | 2010-11-18 |
| DENTLIGHT ORAL EXAM LIGHT KIT (K101140) | Dentlight, Inc. | 2010-07-15 |
| TRIMIRA IDENTAFI 3000 (K090135) | Remicalm, LLC | 2009-02-17 |
| BIO-SCREEN (K082668) | Addent, Inc. | 2009-01-23 |
| TRIMIRA OCS 3000 (K082603) | Remicalm, LLC | 2008-12-12 |
| SAPPHIRE O/E ORAL EXAMINATION SYSTEM (K073483) | Den-Mat Holdings, LLC | 2008-04-03 |
| MODIFICATION TO: VELSCOPE (K070523) | Led Dental, Inc. | 2007-04-05 |
| VELSCOPE (K060920) | Led Medical Diagnostics, Inc. | 2006-04-27 |
Recalls involving this device
No recalls on record reference this clearance.