PASCAL STREAMLINE PHOTOCOAGULATOR— 510(k) K100019
Substantially EquivalentOptimedica Corporation
FDA 510(k) clearance K100019 for PASCAL STREAMLINE PHOTOCOAGULATOR, Substantially Equivalent on 2010-05-04. Applicant: Optimedica Corporation. Device class: 2.
Clearance details
- Applicant
- Optimedica Corporation
- 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
- Sunnyvale, CA, US
Recent devices under product code HQF
view allMore clearances from Optimedica Corporation
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 →
Recalls naming K100019
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100019.
Data sourced from openFDA. This site is unofficial and independent of the FDA.