Paragon HDS

GUDID B22208

Paragon HDS® (paflufocon B) 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 and/or posterior; or, bitoric surfaces in tinted versions. Paragon HDS® rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is 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 Paragon HDS® rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. The Paragon HDS® rigid gas permeable tinted lenses offer color enhancement of the eye and a handling aid for locating the lens. These products may be plasma treated.

PARAGON VISION SCIENCES, INC.

Orthokeratology contact lens

• Primary Device ID: B22208
• NIH Device Record Key: be87357b-fde5-4264-a102-37f4d412be62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paragon HDS
• Version Model Number: Paragon HDS
• Company DUNS: 185530029
• 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: true
• Serial Number: false
• 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	B22208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000224

FDA Product Code

• HQD: Lens, Contact (Other Material) - Daily

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-06
• Device Publish Date: 2018-03-23

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: 2021-04-13 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