510(k) K161012
K161012 is an FDA 510(k) premarket notification submitted by Bausch and Lomb, Inc., for the device "Easy-Load Lens Delivery System". The FDA issued a decision of Substantially Equivalent on July 6, 2016. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2016
- Date Received
- April 11, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Folders And Injectors, Intraocular Lens (Iol)
- Device Class
- Class I
- Regulation Number
- 886.4300
- Review Panel
- OP
- Submission Type