Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens— 510(k) K151961
Substantially EquivalentVolk Optical, Inc.
FDA 510(k) clearance K151961 for Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens, Substantially Equivalent on 2015-08-18. Applicant: Volk Optical, Inc.. Device class: 2.
Clearance details
- Applicant
- Volk Optical, Inc.
- Product code
- Code HJK
- Device class
- Class 2
- Regulation
- 21 CFR 886.1385
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
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