510(k) K122848
K122848 is an FDA 510(k) premarket notification submitted by Lenstec, Inc. for the device "LENSTEC LC INJECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 18, 2013. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Lenstec, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2013
- Date Received
- September 18, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Folders And Injectors, Intraocular Lens (Iol)
- Device Class
- Class I
- Regulation Number
- 886.4300
- Review Panel
- OP
- Submission Type