VARILUX VISIONPRINT SYSTEM (VPS)
FDA 510(k) clearance K033949 · decided 2004-07-02
Clearance details
- K-number
- K033949
- Device name
- VARILUX VISIONPRINT SYSTEM (VPS)
- Applicant
- Essilor Intl.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-19
- Decision date
- 2004-07-02
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- HLL
- Device class
- 2
- Regulation number
- 886.1510
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Washington, DC, 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 |
|---|---|---|
| Retitrack (K222484) | C. Light Technologies, Inc. | 2023-05-09 |
| SACCADOMETER PLUS, SACCADOMETER ADVANCED (K152890) | Ober Consulting Sp. Z.O.O. | 2016-08-11 |
| ORTHOTONE (K872111) | Orthotone Corp. | 1988-11-16 |
Recalls involving this device
No recalls on record reference this clearance.