FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
KOWA SL-17
K Number: K133755
·
Decision Mar 11, 2014
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
16
Review Days
92
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
- KOWA SL-17
- K Number
- K133755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kowa Co. , Ltd.
- Date Received
- December 9, 2013
- Decision Date
- March 11, 2014
- Product Code
- HJO
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HJO), ordered by most recent decision date.
VISUREF 600
FDA 510(k)
FDA Class 2
·Ophthalmic
HP-OCT (HP-OCT)
FDA 510(k)
FDA Class 2
·Ophthalmic
Kowa SL-19
FDA 510(k)
FDA Class 2
·Ophthalmic
MiiS Horus Eye Anterior Camera
FDA 510(k)
FDA Class 2
·Ophthalmic
Sunkingdom Slit Lamp
FDA 510(k)
FDA Class 2
·Ophthalmic
IOLMaster 700
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Kowa Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K112330 | KOWA VX-20 | Feb 16, 2012 | Substantially Equivalent |
| K101628 | KOWA NONMYD WX | Jan 26, 2011 | Substantially Equivalent |
| K091098 | KOWAGENESIS-DF | Aug 7, 2009 | Substantially Equivalent |
| K091039 | KOWA, FM-600, MODEL LSS50 | Aug 7, 2009 | Substantially Equivalent |
| K091683 | KOWA VX-10 A | Jul 2, 2009 | Substantially Equivalent |
| K083387 | MODIFICATION TO KOWA NONMYD ALPHA-DIII | Jan 16, 2009 | Substantially Equivalent |
| K082767 | KOWA NONMYD ALPHA-DIII | Oct 21, 2008 | Substantially Equivalent |
| K080681 | KOWA GENESIS-D | Apr 4, 2008 | Substantially Equivalent |
| K063640 | KOWA SL-15 | Dec 18, 2006 | Substantially Equivalent |
| K062021 | KOWA VX-10I | Nov 1, 2006 | Substantially Equivalent |