Identity
- Trade Name
- Paragon Z CRT FDA UDI
- Generic Name
- Orthokeratology contact lens FDA UDI
- Device Name
- Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). 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”. The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces. Paragon Z CRT Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process. FDA UDI
- Model / Reference
- Paragon Z CRT FDA UDI
- Description
- Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). 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”. The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces. Paragon Z CRT Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B22221 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 Z 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.
- MeniconZ (tisilfocon A) Red — MENICON CO., LTD. · Class III
- Euclid Orthokeratology (tisilfocon 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 (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 015fc0c4-c456-478c-b620-e0d30b994702 33 fields · synced Jun 6, 2026