510(k) K090161
K090161 is an FDA 510(k) premarket notification submitted by Staar Surgical Co. for the device "EPIPHANY INJECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 9, 2009. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Staar Surgical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2009
- Date Received
- January 22, 2009
- Clearance Type
- Traditional
- 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