# K023349: Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)

- Pathway: 510(k) (Traditional)
- Applicant: Contamac, Ltd.
- Decided: Dec 24, 2002 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: 1 generation back to K952620 (1995). 1 ancestor in all.
35 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952620: Optical Blanks: BENZ55G Clear and Visibility Tinted, Benz Research and Development Corp. (1995) Summary page 2.

## Most influential descendants
- K024045: Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut) (2003), 34 descendants of its own
- K073621: Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue Visibility Tint (2008), 33 descendants of its own
- K100221: INTELLIWAVE3 (2010), 32 descendants of its own
- K142641: Intelliwave4 (2015), 12 descendants of its own
- K152046: Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) (2015), 11 descendants of its own

## Indications for use
The CONTAFLEX GM3 58 (acofilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system. Eyecare practitioners may prescribe the lenses for frequendplanned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for fiequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K023349
Methodology: https://510kreport.com/methodology