Clearance Summary
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens received FDA 510(k) clearance under submission number K183167, 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 2019-02-12.
- Submission: K183167
- Applicant / Sponsor: Bausch & Lomb, Incorporated
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 2019-02-12
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.