510(k) K913626
K913626 is an FDA 510(k) premarket notification submitted by Staar Surgical Co. for the device "SOFTRANS INJECTOR". The FDA issued a decision of Substantially Equivalent on December 18, 1991. The device falls under product code HQL (Intraocular Lens), a Class III device regulated under 21 CFR 886.3600. Staar Surgical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1991
- Date Received
- August 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraocular Lens
- Device Class
- Class III
- Regulation Number
- 886.3600
- Review Panel
- OP
- Submission Type