MODEL 1000 OPHTHALMIC LASER SYSTEM— 510(k) K862987
Substantially EquivalentCooperVision, Inc.
FDA 510(k) clearance K862987 for MODEL 1000 OPHTHALMIC LASER SYSTEM, Substantially Equivalent on 1986-09-24. Applicant: CooperVision, Inc.. Device class: 2.
Clearance details
- Applicant
- CooperVision, Inc.
- Product code
- Code HQF
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
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Adverse events under product code HQF
product code HQF- Injury
- 166
- Other
- 1
- Total
- 167
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.