510(k) K171404
K171404 is an FDA 510(k) premarket notification submitted by Bausch + Lomb, Incorporated for the device "BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)". The FDA issued a decision of Substantially Equivalent on July 17, 2017. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Bausch + Lomb, Incorporated has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2017
- Date Received
- May 12, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact (Other Material) - Daily
- Device Class
- Class II
- Regulation Number
- 886.5916
- Review Panel
- OP
- Submission Type