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510(k) Data Aggregation
K Number
K160472Device Name
Hidrocor, Hidrocharme, and Natural Colors
Manufacturer
Date Cleared
2016-08-10
(173 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
SOLOTICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Hidrocor, Hidrocharme, and Natural Colors Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
Device Description
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