Identity
- Trade Name
- FSA 52 FDA UDI
- Generic Name
- Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- FSA 52 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B22214 FDA UDI
- 510(k) Number
- K013310 FDA UDI
- FDA Product Code
- HQD FDA UDI
- GMDN Term
- Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5916 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid-gas-permeable corrective contact lens, daily-wear
Fsa 52 by Paragon Vision Sciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Paragon Vision Sciences
Sources (1)
- FDA UDI 8a68f93e-656b-46b4-a2cb-452d1efd7cee 34 fields · synced Jun 1, 2026