510(k) K872611
K872611 is an FDA 510(k) premarket notification submitted by Solos Ophthalmology for the device "SOLOS EYESITE CAP SLEEVE". The FDA issued a decision of Substantially Equivalent on August 10, 1987. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Solos Ophthalmology has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1987
- Date Received
- July 6, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type