510(k) K925254
K925254 is an FDA 510(k) premarket notification submitted by Allergan Medical Optics for the device "AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38". The FDA issued a decision of Substantially Equivalent on January 7, 1993. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Allergan Medical Optics has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1993
- Date Received
- October 19, 1992
- 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