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 contact lenses with Tangible Hydra-PEG
FDA 510(k) clearance K180172 · decided 2018-03-16
Clearance details
- K-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; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG
- Applicant
- Paragon Vision Sciences
- Decision
- Substantially Equivalent
- Date received
- 2018-01-22
- Decision date
- 2018-03-16
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- HQD
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mesa, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS (P820056/S055) | Paragon Vision Sciences | 1994-01-04 |
| OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS (P820056/S056) | Paragon Vision Sciences | 1994-01-04 |
| OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS (P820056/S054) | Paragon Vision Sciences | 1993-04-14 |
| OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS (P820056/S053) | Paragon Vision Sciences | 1992-11-25 |
| OPTACRYL 60 (KOLFOCON A)RGP BROWN TINT (P820056/S051) | Paragon Vision Sciences | 1992-06-11 |
| OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS (P820056/S052) | Paragon Vision Sciences | 1992-03-30 |
| OPTACRYL 60 (KOLFOCON A)RGP FINISHING LABS (P820056/S050) | Paragon Vision Sciences | 1992-02-25 |
| OPTACRYL 60 - CLEAR (P820056/S049) | Paragon Vision Sciences | 1991-08-15 |