Fluoroperm 60
FluoroPerm® 60 (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…
FluoroPerm® 60 (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 clear and tinted versions. FluoroPerm® 60 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 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 FluoroPerm® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 60 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Who Else Makes It
Registered in Tianjin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tianjin Mastervision Technology Co., Ltd. | Wuqing District | Tianjin | Manufacturer | 2 |
Record
| Listed by | Paragon Vision Sciences, Inc., United States |
|---|---|
| FDA product code | HQD |
| Device type | Lens, Contact (Other Material) – Daily |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5916 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2018-03-23 |
| Record revised | 2026-03-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Fluoroperm 60 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BostonSight Scleral | The Boston Foundation For Sight, Inc. | 17 |
| BostonSight Prose | The Boston Foundation For Sight, Inc. | 17 |
| Acuity | Acuity Polymers Inc. | 6 |
| Custom Stable | Valley Contax, Inc | 4 |
| EyeSpace Bespoke | Tianjin Mastervision Technology Co., Ltd. | 2 |
| EyeSpace Scleral | Tianjin Mastervision Technology Co., Ltd. | 2 |
| Optimum HR 1.53 | Contamac Ltd. | 1 |
| Boston IV | Bausch & Lomb Incorporated | 1 |
| Optimum Extreme | Contamac Ltd. | 1 |
| Oxfore100 | Paragon Vision Sciences, Inc. | 1 |
| Optimum Classic | Contamac Ltd. | 1 |
| SA-18 | Lagado Corporation, THE | 1 |
Showing 12 of 54. All products under Lens, Contact (Other Material) – Daily
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221768 | 2023-05-05 |
| K180172 | 2018-03-16 |
| K120996 | 2012-06-28 |
| K082799 | 2009-01-27 |
| K070637 | 2007-05-01 |
| K052983 | 2006-02-10 |
| K013310 | 2002-04-25 |
| K002845 | 2000-12-08 |
| K993586 | 2000-05-22 |
| K984436 | 1999-04-21 |
| K940277 | 1994-05-09 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P860022 | 1998-03-31 | IPAFLUOROFOCON A AND B | Bausch & Lomb Incorporated |
| P880024 | 1994-03-04 | N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL | The Lagado Corp. |
| P920045 | 1994-02-24 | OP-3 (TM) RGP CONTACT LENS | Stellar Contact Lens, Inc. |
| P890072 | 1994-01-07 | ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS | Progressive Chemical Research, Ltd. |
| P820056 | 1994-01-04 | OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS | Paragon Vision Sciences, Inc. |
| P880035 | 1993-05-19 | VISTACRYL 18(KOLFOCON A) 32(KOFOCON B) RGP LENSES | Vista Optics, Ltd. |
| P890044 | 1993-02-09 | TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES | Rand Scientific Corp. |
| P900001 | 1992-12-04 | RIGID GAS PERMEABLE CONTACT LENSES | THE Lifestyle Co., Inc. |
| P890058 | 1991-07-19 | NOVALENS (ROSILFOCON A) | Ocutec Corporation, Inc. |
| P850038 | 1991-02-05 | PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS | Paragon Optical Co. |
| P880001 | 1990-12-12 | FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS | G.T. Laboratories, Inc. |
| P890046 | 1990-09-10 | O-PERM F60 RGP CONTACT LENS | Optical Polymer Research, Inc. |
| P880041 | 1990-05-08 | MODEL UV44B INTRAOCULAR LENS | Abbott Medical Optics, Inc. |
| P840055 | 1990-03-15 | RIGID GAS PERMEABLE CONTACT LENSES | THE Lifestyle Co., Inc. |
| P840050 | 1986-12-31 | OCUSIL(TM) CONTACT LENS | O.S.I. Corp. |
| P820074 | 1984-06-25 | OPUS – III CONTACT LENSES | Wesley Jessen Corp. |
| P820062 | 1984-03-16 | PARAPERM O2 CLEAR & BLUE LENS | Salvatori Ophthalmics Mfg. Corp. |
| P790010 | 1982-05-28 | DANKER SILICONE LENS (DIMEFOCON-A) | Ciba Vision Gmbh |
| N17878 | 1981-02-24 | MESO(CELLULOSE ACETATE BUTYRATE) HARD CONTACT LENS | Danker Laboratories, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.