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510(k) Data Aggregation
K Number
K013646Device Name
ROSE K POST GRAFT LENS
Manufacturer
ROSE K INTERNATIONAL LTD.
Date Cleared
2002-05-30
(206 days)
Product Code
HQD
Regulation Number
886.5916Why did this record match?
Applicant Name (Manufacturer) :
ROSE K INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rose K Post Graft Rigid Gas Permeable Contact Lens (hexafocon A), and Rose K Post Graft Rigid Gas Permeable Contact Lens (enflufocon B) are indicated for the correction of refractive ametropia in aphakic and nonaphakic patients with keratoconus or following penetrating keratoplasty who may be disabled by conventional contact lenses or spectacles.
Device Description
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