LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER— 510(k) K091675
Substantially EquivalentReimers and Janssen GmbH
FDA 510(k) clearance K091675 for LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER, Substantially Equivalent on 2009-12-15. Applicant: Reimers and Janssen GmbH. Device class: 2.
Clearance details
- Applicant
- Reimers and Janssen GmbH
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berlin, DE
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More clearances from Reimers and Janssen GmbH
view allAdverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
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.