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510(k) Data Aggregation
K Number
K151961Device Name
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
Manufacturer
Volk Optical Inc.
Date Cleared
2015-08-18
(33 days)
Product Code
HJK
Regulation Number
886.1385Why did this record match?
Applicant Name (Manufacturer) :
Volk Optical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.
Device Description
The Volk Disposable Contact Laser and Diagnostic Lenses are a family of diagnostic and therapeutic contact lenses used for eye fundus examinations and therapy of intraocular abnormalities. The family consists of two (2) lenses, including the following: Iridotomy Lens and Capsulotomy Lens.
The family of Volk Disposable Contact Laser and Diagnostic Lenses are designed around the classic Volk Contact Laser and Diagnostic Lenses. Each model lens is similar in design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use.
The lenses are provided sterile for single use.
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