FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
K Number: K111493
·
Decision Jul 27, 2011
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
29
Applicant Total
20
Review Days
57
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Basic Information
- Device Name
- NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
- K Number
- K111493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4690
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nidek Co., Ltd.
- Date Received
- May 31, 2011
- Decision Date
- July 27, 2011
- Product Code
- HQB
- 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 |
|---|---|---|---|
| HQB | Photocoagulator And Accessories | FDA class 2 | Ophthalmic |
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