# K030593: Flexlens and Harrison Post Refractive Surgery (Bioxifilcon a), (Hioxifilcon B), (Acofilcon a), (Acofilcon B) Soft Contac

- Pathway: 510(k) (Traditional)
- Applicant: X-Cel Contacts, A Walman Co.
- Decided: May 30, 2003 after 94 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 K950294 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950294: Flexlens 55 Soft (Hydrophilic) Contact Lens, Flexlens, Inc. (1996) Summary page 2.
- K961943: Flexlens, Flexlens, Inc. (1996) Summary page 2.

## Cited in the summary but kept off the family tree
- K950295: Wound Closure/Laceration Tray, Customed, Inc. (1995). Our OCR of the scanned summary read K950295, FDA’s number for Wound Closure/Laceration Tray (Customed, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Flexlens 55 Soft (Hydrophilic)”. Kept off the family tree.

## Indications for use
The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia. Examples include, but are not limited to: adult and pediatric aphakia, and irregular astigmatism created by keratoconus, trauma, or post keratoplasty. The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery. The lens may be disinfected with a chemical (not heat) disinfection system.

Source page: https://510kreport.com/device/K030593
Methodology: https://510kreport.com/methodology