# K983637: Actifresh 400 Lens

- Pathway: 510(k) (Traditional)
- Applicant: Hydron, Ltd.
- Decided: Dec 10, 1999 after 420 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 P830047 (1985). 1 ancestor in all.
33 later devices descend from it; 7 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P830047: X-70 Soft Contact Lens, Advanced Medical Optics, Inc. (1985) Summary page 1.

## Most influential descendants
- 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
- K161100: Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses (2016), 8 descendants of its own
- K100244: Metro Soft (2010), 8 descendants of its own

## Indications for use
The Hydron ActiFresh 400 (lidofilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. Eyecare practitioners may prescribe the lens for frequent replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.

Source page: https://510kreport.com/device/K983637
Methodology: https://510kreport.com/methodology