# K152657: SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Smart Performer Corp., Ltd.
- Decided: May 17, 2016 after 244 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: 6 generations back to K942214 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141280: Ilens (Ocufilcon D) Daily Soft Contact Lens, Seinoh Optical Co., Ltd. (2014) Summary page 4.
- K013377: Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens, Ocular Sciences Puerto Rico, Inc. (2001) 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 55 (Ocufilcon D) 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 1.00D 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 single-use disposable daily wear. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.

Source page: https://510kreport.com/device/K152657
Methodology: https://510kreport.com/methodology