LASER LENS-VARIOUS MODELS— 510(k) K834610
Substantially EquivalentMeditec of America
FDA 510(k) clearance K834610 for LASER LENS-VARIOUS MODELS, Substantially Equivalent on 1984-04-05. Applicant: Meditec of America. Device class: 2.
Clearance details
- Applicant
- Meditec of America
- 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
- Walker, MI, US
Recent devices under product code HQF
view allMore clearances from Meditec of America
view allAdverse 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.