FSA 52
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Basic Information
- Brand Name
- FSA 52
- Primary DI
- B22214
- Version / Model
- FSA 52
- Company Name
- Paragon Vision Sciences, Inc.
- Labeler DUNS
- 028594987
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-16
- Public Version
- 4
- Public Version Date
- 2026-03-17
- Public Version Status
- Update
- Public Device Record Key
- 8a68f93e-656b-46b4-a2cb-452d1efd7cee
Device Description
FSA 52 (migafocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior, posterior or bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The FSA 52 (migafocon A) rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomer. The FSA 52 (migafocon A) rigid gas permeable tinted lenses offer color enhancement of the eye and a handling aid for locating the lens.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | Ophthalmic | 886.5916 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47840 | Rigid-gas-permeable corrective contact lens, daily-wear, non-customized | A prefabricated (non-customized) rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B22214 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013310 | 000 |