510(k) K161461
K161461 is an FDA 510(k) premarket notification submitted by Bostonsight for the device "BostonSight PD Prosthetic Device". The FDA issued a decision of Substantially Equivalent on July 25, 2016. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Bostonsight has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2016
- Date Received
- May 26, 2016
- 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