Clearance Summary
SLIT LAMP BO 900, BQ 900, BP900 received FDA 510(k) clearance under submission number K100202, sponsored by Haag-Streit AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2010-03-19.
- Submission: K100202
- Applicant / Sponsor: Haag-Streit AG
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2010-03-19
Classification & Regulation
This clearance is catalogued under FDA product code HJO and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.