FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INNOVATOME MICROKERATOME
K Number: K973294
·
Decision Oct 3, 1997
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
1
Review Days
31
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
- INNOVATOME MICROKERATOME
- K Number
- K973294
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Optics, Inc.
- Date Received
- September 2, 1997
- Decision Date
- October 3, 1997
- Product Code
- HNO
- 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNO), ordered by most recent decision date.
VisuMax Femtosecond Laser
FDA 510(k)
FDA Class 1
·Ophthalmic
EPI K Console
FDA 510(k)
FDA Class 1
·Ophthalmic
EPIVISION SL SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
CARRIAZO-PENDULAR MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
ZYOPTIX XP EPI SEPARATOR SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic