510(k) K981063
K981063 is an FDA 510(k) premarket notification submitted by Laser Center Dev. Corp. for the device "AUTOMATED CORNEAL TREPHINE". The FDA issued a decision of Substantially Equivalent on June 23, 1998. The device falls under product code HRG (Engine, Trephine, Accessories, Ac-Powered), a Class I device regulated under 21 CFR 886.4070. Laser Center Dev. Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1998
- Date Received
- March 23, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Engine, Trephine, Accessories, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.4070
- Review Panel
- OP
- Submission Type