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510(k) K033599

ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS by The Lagado Corp. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2004
Date Received
November 14, 2003
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 The Lagado Corp.

  • K120756 — LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) (May 13, 2013)
  • K130285 — PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS (April 3, 2013)
  • K102154 — TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, (January 21, 2011)
  • K052507 — TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL C (November 2, 2005)

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