# K971049: Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Vision Care, Ltd.
- Decided: May 21, 1997 after 61 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 K950283 (1995). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963001: Lifestyle 4-Vue (Polymacon) Hydrophilic Multifocal Contact Lens for Daily Wear, Permeable Technologies, Inc. (1997). Our OCR of the scanned summary read K863001, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “LifeStyle 4-Vue (polymacon) Hydrophilic Contact Lens for Daily Wear…”.
- K950283: Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact Lens, Permeable Technologies, Inc. (1995) Summary page 1.
- K963001: Lifestyle 4-Vue (Polymacon) Hydrophilic Multifocal Contact Lens for Daily Wear, Permeable Technologies, Inc. (1997). Our OCR of the scanned summary read K983001, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “LifeStyle 4-Vue (polymacon) Hydrophilic Contact Lens for Daily Wear…”.

## Cited in the summary but kept off the family tree
- K850283: LifeStyle 4-Vue (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K042824: Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens (2004), 5 descendants of its own
- K984259: Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted) (1999), 4 descendants of its own
- K123973: Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses (2013), 2 descendants of its own
- K992950: Custom Prosthetic (Hefilcon a) Soft Lens (1999), 2 descendants of its own
- K182674: Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (2018), 1 descendant of its own

## Indications for use
The FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens (clear and tinted) 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 astigmatism up to 2.00 Diopters that does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K971049
Methodology: https://510kreport.com/methodology