# K173944: Endocular Viewing Lenses and Silicone Ring

- Pathway: 510(k) (Traditional)
- Applicant: Phakos
- Decided: Oct 25, 2018 after 303 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: 3 generations back to K943125 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012096: Disposable Vitrectomy Lens, Ocular Instruments, Inc. (2001) Summary page 4.
- 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 4.
- K151961: Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens, Volk Optical, Inc. (2015) Summary page 4.
- K140368: Family of Disposable Lenses, Sensor Medical Technology, LLC (2014) Summary page 4.
- K142715: Sensor Medical Family of Vitrectomy Lenses and Products, Sensor Medical Technology, LLC (2014) Summary page 4.

## Indications for use
The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations of the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, as well as other ocular structures during surgical procedures or consultation.

Source page: https://510kreport.com/device/K173944
Methodology: https://510kreport.com/methodology