INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)
FDA 510(k) clearance K950077 · decided 1995-06-14
Clearance details
- K-number
- K950077
- Device name
- INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)
- Applicant
- Par Vision Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-10
- Decision date
- 1995-06-14
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- MMQ
- Device class
- 1
- Regulation number
- 886.1350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- New Hartford, NY, 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 |
|---|---|---|
| SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE (K981665) | Bio-Medical Sciences, Inc. | 1998-12-07 |
| EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 (K964702) | Euclid Systems Corp. | 1997-05-20 |
| ORBSHOT KERATOMETER (K964891) | Orbtek, Inc. | 1997-03-26 |
| CORNEAL TOPOGRAPHER 200 (K963762) | Eclipse Ventures | 1996-12-23 |
Recalls involving this device
No recalls on record reference this clearance.