# K110452: Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2,

- Pathway: 510(k) (Special)
- Applicant: Unilens Corp., USA
- Decided: Apr 20, 2011 after 63 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: 7 generations back to P810005 (1981). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820005: (Polymacon) Contact Lenses, Salvatori Ophthalmics Mfg. Corp.. FDA lists this PMA only through its supplements; the earliest we hold is P820005/S001 (Jul 21, 1982). Summary page 1.
- P850002: Alges (TM) (Hefilcon a) Contact Lens, Unilens Corp., USA. FDA lists this PMA only through its supplements; the earliest we hold is P850002/S001 (Feb 28, 1986). Summary page 1.
- P880101: Aquaflex[Tetrafilcon a] Contact Lenses/Shelf Life, Unilens Corporation, USA. FDA lists this PMA only through its supplements; the earliest we hold is P880101/S003 (Mar 5, 1990). Summary page 1.
- P880102: Lombart (Polymacon) Soft Contact Lenses, Lombart Lenses, Ltd.. FDA lists this PMA only through its supplements; the earliest we hold is P880102/S001 (Mar 5, 1992). Summary page 1.
- K940777: Bayvue (Polymacon) Soft (Hydrophilic) Contact Lens, Unilens Corp., USA (1994) Summary page 1.
- K941836: Unilens 38 Soft Aspheric Contact Lens, Unilens Corp., USA (1994) Summary page 1.
- K942372: Simulvue 38 (Polymacon) Soft (Hydrophilic) Bifocal Contact Lens, Unilens Corp., USA (1994) Summary page 4.
- K942494: Lifestyle Multivue-S (Polymacon) Soft Hydrophilic Contact Lens, Permeable Technologies, Inc. (1994) Summary page 1.
- K960926: Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens, Unilens Corp., USA (1996) Summary page 1.
- K961428: Soft-55 Daily Wear Contact Lens, Lombart Lenses, Ltd. (1996) Summary page 1.
- K965012: Lifestyle Break Thru (Polymacon), The Lifestyle Co., Inc. (1997) Summary page 1.
- K971647: LL BI-Focal, Daily Wear Contact Lens, Lombart Lenses, Ltd. (1997) Summary page 1.
- K000529: Lifestyle MV2 (TM) Toric (Polymacon) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear (Clear or Tinted), The Lifestyle Co., Inc. (2000) Summary page 1.
- K002408: Axion Plus (Methafilcon a) Soft (Hydrophilic) Aspheric Contract Lens, Unilens Corp., USA (2000) Summary page 1.
- K041608: C-Vue 55 Toric (Methafilcon a) Multifocal Contact Lens, Unilens Corp., USA (2004) Summary page 1.
- K050743: Aquaflex 2 (Tefilcon) Contact Lens, Unilens Corp., USA (2005) Summary page 1.
- K082393: Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens, Unilens Corp., USA (2008) Summary page 1.
- K100456: Cvue Advanced Definitive, Unilens Corp., USA (2010) Summary page 1.

## Indications for use
For parametric release from Moist Heat Sterilization of Hydrophilic Contact Lenses

Source page: https://510kreport.com/device/K110452
Methodology: https://510kreport.com/methodology