# K041700: Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Cantor & Nissel, Ltd.
- Decided: Jul 30, 2004 after 38 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961103 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992950: Custom Prosthetic (Hefilcon a) Soft Lens, Prosthetic Soft Lens Corp. (1999) Summary page 2.

## Indications for use
The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens is disinfected using a hydrogen peroxide lens care system only.

Source page: https://510kreport.com/device/K041700
Methodology: https://510kreport.com/methodology