Identity
- Trade Name
- Paragon CRT FDA UDI
- Generic Name
- Orthokeratology contact lens FDA UDI
- Device Name
- Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, A mathematically designed sigmoidal corneal proximity “Return Zone” and A non-curving “Landing Zone”. Paragon CRT® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, violet and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Violet No. 2 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated. FDA UDI
- Model / Reference
- Paragon CRT FDA UDI
- Description
- Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, A mathematically designed sigmoidal corneal proximity “Return Zone” and A non-curving “Landing Zone”. Paragon CRT® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, violet and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Violet No. 2 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B22217 FDA UDI
- FDA Product Code
- NUU FDA UDI
- GMDN Term
- Orthokeratology contact lens FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthokeratology contact lens
Paragon CRT by Paragon Vision Sciences — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthokeratology contact lens.
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- Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
- Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
- Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
- Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
- Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
- Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear — EUCLID VISION CORPORATION · Class III
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 III | Pending data |
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Manufacturer
- Manufacturer
- Paragon Vision Sciences
Sources (1)
- FDA UDI fd6fa2a6-9d11-4060-97ce-e661f186d4c7 33 fields · synced May 30, 2026