Visalis V500, Visalis S500
FDA 510(k) clearance K193376 · decided 2020-06-15
Clearance details
- K-number
- K193376
- Device name
- Visalis V500, Visalis S500
- Applicant
- Carl Zeiss Meditec, AG
- Decision
- Substantially Equivalent
- Date received
- 2019-12-05
- Decision date
- 2020-06-15
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Jena, DE
- 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER (P990048/S003) | Carl Zeiss Meditec, AG | 2008-10-31 |
| VISULAS 690S AND VISULINK PDT/U ADAPTER (P990048/S001) | Carl Zeiss Meditec, AG | 2001-09-27 |
| VISULAS 690S LASER AND VISULINK PDT ADAPTER (P990048/S002) | Carl Zeiss Meditec, AG | 2001-07-03 |
| ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER (P990048) | Carl Zeiss Meditec, AG | 2000-04-12 |
| MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES (P830056/S079) | Carl Zeiss Meditec, AG | 1999-05-11 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION) (P830056/S078) | Carl Zeiss Meditec, AG | 1998-01-29 |
| POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S077) | Carl Zeiss Meditec, AG | 1996-08-01 |
| POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S075) | Carl Zeiss Meditec, AG | 1996-04-02 |