Clearance Summary
Spectralis HRA+OCT and Variants received FDA 510(k) clearance under submission number K192391, sponsored by Heidelberg Engineering GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2019-09-26.
- Submission: K192391
- Applicant / Sponsor: Heidelberg Engineering GmbH
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2019-09-26
Classification & Regulation
This clearance is catalogued under FDA product code OBO and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.