510(k) K132593
K132593 is an FDA 510(k) premarket notification submitted by Bausch & Lomb for the device "CRYSTALSERT DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 17, 2013. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Bausch & Lomb has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2013
- Date Received
- August 19, 2013
- 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