A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5— 510(k) K002986
Substantially EquivalentA.R.C. Laser AG
FDA 510(k) clearance K002986 for A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5, Substantially Equivalent on 2000-11-29. Applicant: A.R.C. Laser AG.
Clearance details
- Applicant
- A.R.C. Laser AG
- Product code
- Code HQC
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
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.