Clearance Summary
FAMILY OF DISPOSABLE LENSES received FDA 510(k) clearance under submission number K140368, sponsored by Sensor Medical Technology, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2014-04-29.
- Submission: K140368
- Applicant / Sponsor: Sensor Medical Technology, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1660
- Decision date: 2014-04-29
Classification & Regulation
This clearance is catalogued under FDA product code HKS and 21 CFR 886.1660, within the Ophthalmic review panel as a Class I device.