Last synced on 4 February 2023 at 10:33 pm

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180172
510(k) Type
Traditional
Applicant
Paragon Vision Sciences
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/16/2018
Days to Decision
53 days
Submission Type
Summary

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180172
510(k) Type
Traditional
Applicant
Paragon Vision Sciences
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/16/2018
Days to Decision
53 days
Submission Type
Summary