Clearance Summary
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 received FDA 510(k) clearance under submission number K070270, sponsored by Kirchner & Wilhelm GmbH + Co.Kg. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2007-11-05.
- Submission: K070270
- Applicant / Sponsor: Kirchner & Wilhelm GmbH + Co.Kg
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2007-11-05
Classification & Regulation
This clearance is catalogued under FDA product code HLJ and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.