Paragon RG-4

GUDID B22220

Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consisting of four zones: The central spherical or aspheric zone, an annular “Reverse Zone(s)”surrounding the central zone with a curvature steeper (shorter radius) than the central zone, an “Alignment Zone(s)” generally paralleling the underlying corneal surface and peripheral curve(s) with a radius selected to create “edge lift” to promote tear flow under the lens and avoid impingement of the peripheral curve on the cornea. The lens design also includes a “rounded” edge terminus extending from the anterior to the posterior surfaces to promote comfort. Paragon RG-4 Contact Lenses for Corneal Reshaping are to be worn overnight with removal during all or part of each following day. The material is a 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 reshaping are available as lathe cut firm contact lenses with blue, green, red and yellow tints containing D&C Green No. 6, D&C Red No. 17 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.

Paragon Vision Sciences, Inc.

Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens

• Primary Device ID: B22220
• NIH Device Record Key: be721012-a511-49b1-a2f1-7679a64b8145
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paragon RG-4
• Version Model Number: Paragon RG-4
• Company DUNS: 028594987
• Company Name: Paragon Vision Sciences, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B22220 [Primary]

FDA Product Code

• NUU: Lens, Contact, Orthokeratology, Overnight

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-13
• Device Publish Date: 2021-04-05

Devices Manufactured by Paragon Vision Sciences, Inc.

• B22225 - Oxfore100: 2023-09-26 The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut int
• B22217 - Paragon CRT: 2021-04-13 Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). The lenses are designed to have congruent anter
• B22218 - Paragon CRT100: 2021-04-13 Paragon CRT® 100 Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congru
• B22219 - Paragon CRT Dual Axis: 2021-04-13 Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B), Paragon CRT® 100 Contact Lenses and Paragon C
• B22220 - Paragon RG-4: 2021-04-13Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consisting of four zones: The central spherical or aspheric zone, an annular “Reverse Zone(s)”surrounding the central zone with a curvature steeper (shorter radius) than the central zone, an “Alignment Zone(s)” generally paralleling the underlying corneal surface and peripheral curve(s) with a radius selected to create “edge lift” to promote tear flow under the lens and avoid impingement of the peripheral curve on the cornea. The lens design also includes a “rounded” edge terminus extending from the anterior to the posterior surfaces to promote comfort. Paragon RG-4 Contact Lenses for Corneal Reshaping are to be worn overnight with removal during all or part of each following day. The material is a 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 reshaping are available as lathe cut firm contact lenses with blue, green, red and yellow tints containing D&C Green No. 6, D&C Red No. 17 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.
• B22220 - Paragon RG-4: 2021-04-13 Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consist
• B22221 - Paragon Z CRT: 2021-04-13 Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterio
• B22222 - Paragon Z CRT Dual Axis: 2021-04-13 Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congrue
• B22202 - Paraperm O2: 2019-05-06 Paraperm® O2 (pasifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact