510(k) K990264
K990264 is an FDA 510(k) premarket notification submitted by Metro Optics of Austin, Inc. for the device "COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS". The FDA issued a decision of Substantially Equivalent on March 31, 1999. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Metro Optics of Austin, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1999
- Date Received
- January 27, 1999
- 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