Clearance Summary
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) received FDA 510(k) clearance under submission number K171404, sponsored by Bausch + Lomb, Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2017-07-17.
- Submission: K171404
- Applicant / Sponsor: Bausch + Lomb, Incorporated
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 2017-07-17
Classification & Regulation
This clearance is catalogued under FDA product code HQD and 21 CFR 886.5916, within the Ophthalmic review panel as a Class II device.