FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)
K Number: K950077
·
Decision Jun 14, 1995
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
4
Applicant Total
1
Review Days
155
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)
- K Number
- K950077
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Par Vision Systems Corp.
- Date Received
- January 10, 1995
- Decision Date
- June 14, 1995
- Product Code
- MMQ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MMQ | Topographer, Corneal, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MMQ), ordered by most recent decision date.
SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
FDA 510(k)
FDA Class 1
·Ophthalmic
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
FDA 510(k)
FDA Class 1
·Ophthalmic
ORBSHOT KERATOMETER
FDA 510(k)
FDA Class 1
·Ophthalmic
CORNEAL TOPOGRAPHER 200
FDA 510(k)
FDA Class 1
·Ophthalmic