NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI— 510(k) K111493
Substantially EquivalentNidek Co., Ltd.
FDA 510(k) clearance K111493 for NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI, Substantially Equivalent on 2011-07-27. Applicant: Nidek Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Nidek Co., Ltd.
- Product code
- Code HQB
- Device class
- Class 2
- Regulation
- 21 CFR 886.4690
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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More clearances from Nidek Co., Ltd.
view allAdverse events under product code HQB
product code HQB- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.