Clearance Summary
HEINE OMEGA 500 received FDA 510(k) clearance under submission number K123316, 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 2013-02-26.
- Submission: K123316
- 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: 2013-02-26
Classification & Regulation
This clearance is catalogued under FDA product code HLI and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.