LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II— 510(k) K003512
Substantially EquivalentA.R.C. Laser AG
FDA 510(k) clearance K003512 for LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II, Substantially Equivalent on 2001-02-08. 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.