NIDEK AC-2000 LASER SYSTEM— 510(k) K860011

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K860011 for NIDEK AC-2000 LASER SYSTEM, Substantially Equivalent on 1986-02-07. Applicant: Nidek, Inc..

Clearance details

Applicant: Nidek, Inc.
Product code: Code HQB
Advisory panel: Ophthalmic
Date received: 1986-01-03
Decision date: 1986-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQB

product code HQB

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.