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510(k) K990264

COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS by Metro Optics of Austin, Inc. — Product Code HQD

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

Other clearances by Metro Optics of Austin, Inc.

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  • K080512 — REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AN (July 23, 2008)
  • K031532 — SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS F (August 1, 2003)
  • K001620 — METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & (June 13, 2000)
  • K964902 — CONTACT LENSES METRO-G 3X (HIOXIFILCON B) (March 11, 1997)
  • K961606 — METRO FOCAL ASPHERIC (POLYMACON) (November 20, 1996)

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