# K992500: Cantor & Silver 5X Prosthetic Tinted (Hioxifilcon a) Soft Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Cantor & Silver, Ltd.
- Decided: Aug 18, 1999 after 23 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alden Classic Prosthetic Tinted Soft Contact Lens: named in the summary without a submission number
- (no number) CANTOR & SILVER 5X Tinted: named in the summary without a submission number

## Indications for use
The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are 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 are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.

Source page: https://510kreport.com/device/K992500
Methodology: https://510kreport.com/methodology