# K151847: SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Smart Performer Corp., Ltd.
- Decided: Mar 4, 2016 after 241 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 K960926 (1996). 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)
- K082883: Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily Wear, I-See Vision Technology, Inc. (2009) Summary page 4.
- K001089: Polymacon, CooperVision, Inc. (2000) Summary page 4.
- K010114: Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance the Natural Iris Color), Johnson & Johnson Vision Care, Inc. (2001) Summary page 4.

## Indications for use
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is intended to use as correction of refractive myopia in aphakic or non-aphakic persons with non-diseased eyes, who may have 1.00 D of astigmatism or less. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye. Eyecare practitioners may prescribe the contact lens for frequent replacement wear, with cleaning. rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system. Note: decorative contact lens is a medical device that can only be used with a valid contact lens prescription.

Source page: https://510kreport.com/device/K151847
Methodology: https://510kreport.com/methodology