NIDEK AC-2000 LASER SYSTEM— 510(k) K860011
Substantially EquivalentNidek, Inc.
FDA 510(k) clearance K860011 for NIDEK AC-2000 LASER SYSTEM, Substantially Equivalent on 1986-02-07. Applicant: Nidek, Inc.. Device class: 2.
Clearance details
- Applicant
- Nidek, Inc.
- 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
- Palo Alto, CA, US
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More clearances from Nidek, Inc.
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.