# K151961: Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens

- Pathway: 510(k) (Special)
- Applicant: Volk Optical, Inc.
- Decided: Aug 18, 2015 after 33 days
- Product code: HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 886.1385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943125 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943125: Quadraspheric Fundus Lens, Volk Optical, Inc. (1994) Summary page 4.
- K023221: Contact Laser & Diagnostic Lenses, Volk Optical, Inc. (2002) Summary page 5.
- K050623: Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D, Volk Optical, Inc. (2005) Summary page 5.

## Most influential descendants
- K173944: Endocular Viewing Lenses and Silicone Ring (2018), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K151961
Methodology: https://510kreport.com/methodology