# K992950: Custom Prosthetic (Hefilcon a) Soft Lens

- Pathway: 510(k) (Traditional)
- Applicant: Prosthetic Soft Lens Corp.
- Decided: Nov 18, 1999 after 78 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: 3 generations back to K961103 (1996). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984259: Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted), Cl-Tinters (1999) Summary page 1.
- K983053: Alden Classic Prosthetic (Polymacon) Tinted, Soft Daily Wear Contact Lens (Sighted and Non-Sighted Eyes), Alden Optical Labs., Inc. (1998) Summary page 1.
- K983278: Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted an Non-Sighted Eyes), Alden Optical Labs., Inc. (1998) Summary page 1.

## Most influential descendants
- K041700: Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily Wear (2004), 0 descendants of its own
- K020690: Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact Lens (2002), 0 descendants of its own

## Indications for use
The Prosthetic (hefilcon A) Soft Contact Lens is indicated for daily wear to enhance or alter the appearance of the eye, including ocular masking, in sighted or non-sighted eyes, that may require a prosthetic contact lens for the cosmetic management of corneal, iris, scleral or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or non-aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with a chemical disinfection system.

Source page: https://510kreport.com/device/K992950
Methodology: https://510kreport.com/methodology