Clearance Summary
LIFELINES PHOTIC STIMULATOR received FDA 510(k) clearance under submission number K101691, sponsored by Lifelines , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2010-08-10.
- Submission: K101691
- Applicant / Sponsor: Lifelines , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1890
- Decision date: 2010-08-10
Classification & Regulation
This clearance is catalogued under FDA product code GWE and 21 CFR 882.1890, within the Neurology review panel as a Class II device.