510(k) K024164
K024164 is an FDA 510(k) premarket notification submitted by Metro Optics, Inc. for the device "COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT". The FDA issued a decision of Substantially Equivalent on Feb 12, 2003. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 12, 2003
- Date Received
- Dec 17, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Lens, Contact (Other Material) - Daily
- Device Class
- Class II
- Regulation Number
- 886.5916
- Review Panel
- OP
- Submission Type
- 510(k)