# K023221: Contact Laser & Diagnostic Lenses

- Pathway: 510(k) (Special)
- Applicant: Volk Optical, Inc.
- Decided: Oct 11, 2002 after 14 days
- Product code: HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 886.1385
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K151961: Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (2015), 1 descendant of its own
- K051103: Haag-Streit Contact Glasses Stery Cup, Accessory (2005), 1 descendant of its own
- K173944: Endocular Viewing Lenses and Silicone Ring (2018), 0 descendants of its own
- K052674: Contact Lens Ophthalmodynamometer (2006), 0 descendants of its own

## Recalls of this device
- Feb 27, 2015 · Class III · Z-1685-2015: Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.

## Indications for use
The device is indicated for use as a diagnostic contact lens for eye fundus examinations and use in the therapy of intraocular abnormalities.

Source page: https://510kreport.com/device/K023221
Methodology: https://510kreport.com/methodology