FDA.reportPublic FDA data

Paragon HDS

Primary DI
B22208
Brand
Paragon HDS
Company
Paragon Vision Sciences, Inc.
Model
Paragon HDS
Device description
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.
Published
2018-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HQDLens, Contact (Other Material) - Daily
MUWLens, Contact (Orthokeratology)
MWLLens,Contact(Rigid Gas Permeable)-Extended Wear
NUULens, Contact, Orthokeratology, Overnight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQDLens, Contact (Other Material) - DailyOphthalmic2
MUWLens, Contact (Orthokeratology)Ophthalmic2
MWLLens, Contact (Rigid Gas Permeable), Extended WearOphthalmic3
NUULens, Contact, Orthokeratology, OvernightOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000224000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000224000FLUROPERM 60-OK, PARAGON HDS-OKParagon Vision Sciences2000-04-17MUW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B22208PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthokeratology contact lensA rigid-gas-permeable ophthalmic lens intended to be worn directly against the cornea of the eye for orthokeratology (Ortho-K), a procedure where the lens is worn for several hours, typically each night, to modify the curvature of the cornea as an alternative method to correct refractive vision conditions. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028594987
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B22221Paragon Z CRT Paragon Z CRT 2021-04-05
B22222Paragon Z CRT Dual Axis Paragon Z CRT Dual Axis2021-04-05
B22203Paraperm EWParaperm EW2018-02-23
B22211FSA 38FSA 382018-03-16
B22214FSA 52FSA 522018-03-16
B22215SportSight GPSportSight GP2018-02-23
B22216HDS HI 1.54HDS HI 1.542018-02-02
B222700Single Lens BillBoard7002017-12-08
B222750Bi-Lens BillBoard7502017-12-08
B22201Optacryl 60Optacryl 602017-10-24
B22225Oxfore100Oxfore1002023-09-18
B22202Paraperm O2Paraperm O22018-02-23
B22204Fluoroperm 92Fluoroperm 922018-03-23
B22205Fluoroperm 60Fluoroperm 602018-03-23
B22206Fluoroperm 30Fluoroperm 302018-03-23
B22207Fluoroperm 151Fluoroperm 1512018-03-23
B22209Paragon HDS100Paragon HDS1002018-03-23
B22212Paragon ThinParagon Thin2018-03-23
B22217Paragon CRTParagon CRT 2021-04-05
B22218Paragon CRT100Paragon CRT 1002021-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850007135515Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135522Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135539Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135546Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000183Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000190Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000206Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000213Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000244Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000251Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000268Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000275Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000282Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000299Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000305Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000312Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000329Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000336Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000343Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000350Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099965Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099972Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099989Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099996Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10850007135604Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10850007135611Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501468Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501475Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501512Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501529Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05