# K032256: Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas Permeable (RGP) Daily Wear Contact LE

- Pathway: 510(k) (Traditional)
- Applicant: No 7 Contact Lens Laboratory, Ltd.
- Decided: Aug 29, 2003 after 38 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: 2 generations back to K942365 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970698: Boston ES Multivision (Enflufocon a) Contact Lens, Polymer Technology Corp. (1997) Summary page 2.
- K000795: Rigid Gas Permeable Contact Lens, Polymer Technology (2000)
- K021977: Hybrid FS & Hybrid FS Toric (Hycofocon a) RGP Contact Lens for Daily Wear, Contamac, Ltd. (2002)
- P870024: Fluoroperm RGP Contact Lenses, CooperVision, Inc. (1987) Summary page 2.

## Indications for use
The QUASAR@(hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only. The QUASAR TORIC@(hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia andor possesses retiactive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only. The QUASAR PLUS@(hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia andor possesses rehctive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only.

Source page: https://510kreport.com/device/K032256
Methodology: https://510kreport.com/methodology