Clearance Summary
HEINE SIGMA 250 & HEINE SIGMA 250 M2 received FDA 510(k) clearance under submission number K142837, sponsored by Heine Optotechnik GmbH & Co. KG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2015-01-29.
- Submission: K142837
- Applicant / Sponsor: Heine Optotechnik GmbH & Co. KG
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2015-01-29
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.