510(k) K871649
K871649 is an FDA 510(k) premarket notification submitted by Korea Asahi Optical Co., Ltd. for the device "CLASSIC 70 LENS". The FDA issued a decision of Substantially Equivalent on May 29, 1987. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Korea Asahi Optical Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 1987
- Date Received
- April 29, 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