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510(k) K130285

PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS by The Lagado Corp. — Product Code LRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2013
Date Received
February 5, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
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)
  • 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)
  • K033599 — ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCA (September 16, 2004)

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