Paraperm O2
GUDID B22202
Paraperm® O2 (pasifocon 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 and/or 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 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 Paraperm® O2 rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The Paraperm® O2 rigid gas permeable tinted lenses offer a handling aid for locating the lens.
PARAGON VISION SCIENCES, INC.
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| NIH Device Record Key | ce284c96-5a91-42db-8f6e-2fce2368e05a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Paraperm O2 |
| Version Model Number | Paraperm O2 |
| 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 | B22202 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P820063
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 | 4 |
| Public Version Date | 2019-05-06 |
| Device Publish Date | 2018-02-23 |
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 | 2019-05-06Paraperm® O2 (pasifocon 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 and/or 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 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 Paraperm® O2 rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The Paraperm® O2 rigid gas permeable tinted lenses offer a handling aid for locating the lens. |
| 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 |
Trademark Results [Paraperm O2]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PARAPERM O2 73312764 1239039 Dead/Cancelled |
Paragon Optical, Inc. 1981-06-01 |
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