The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for 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; Fl.
| Device ID | K180172 |
| 510k Number | K180172 |
| Device Name: | 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; Fl |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | Paragon Vision Sciences 974 E Impala Ave Mesa, AZ 85204 |
| Contact | Rich Jefferies |
| Correspondent | Bret James Andre EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-03-16 |
| Summary: | summary |