510(k) K053475
K053475 is an FDA 510(k) premarket notification submitted by Refractec, Inc. for the device "OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450". The FDA issued a decision of Substantially Equivalent on March 3, 2006. The device falls under product code HMR (Marker, Ocular), a Class I device regulated under 21 CFR 886.4570. Refractec, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2006
- Date Received
- December 14, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Ocular
- Device Class
- Class I
- Regulation Number
- 886.4570
- Review Panel
- OP
- Submission Type