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510(k) K080512

REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT by Metro Optics of Austin, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2008
Date Received
February 25, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

Other clearances by Metro Optics of Austin, Inc.

  • K233221 — Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (February 6, 2024)
  • K100244 — METRO SOFT (October 28, 2010)
  • 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)
  • K990264 — COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT (March 31, 1999)
  • K964902 — CONTACT LENSES METRO-G 3X (HIOXIFILCON B) (March 11, 1997)
  • K961606 — METRO FOCAL ASPHERIC (POLYMACON) (November 20, 1996)

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