# K241398: SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Mastervision Technology Co., Ltd.
- Decided: Oct 22, 2024 after 159 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K943177 (1994). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240618: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens, Acuity Polymers, Inc. (2024) Summary page 6.
- K201194: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, Acuity Polymers, Inc. (2020) Summary page 6.
- K203571: Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, Acuity Polymers, Inc. (2021) Summary page 6.

## Indications for use
The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjogren’s syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error. The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K241398
Methodology: https://510kreport.com/methodology