Custom Stable
Custom Stable is a daily-wear rigid gas-permeable scleral contact lens. Its large-diameter design vaults over the cornea and rests on the conjunctiva above the sclera. The lens is lathe-cut…
Custom Stable is a daily-wear rigid gas-permeable scleral contact lens. Its large-diameter design vaults over the cornea and rests on the conjunctiva above the sclera.
The lens is lathe-cut from roflufocon D or roflufocon E fluorosilicone-acrylate material. Clear and tinted versions are available, including the listed Optimum material configurations.
Listed Item
Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Light Blue material
Lens Parameters and Supply
The design offers diameters from 13.8 to 19.0 mm with different curves, thicknesses and optical powers to fit the eye. It is intended for managing specified ocular conditions, including irregular corneal shapes. Lenses may be shipped dry or in the specified multipurpose solution, with the selected prescription defining the individual lens geometry.
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 | Valley Contax, Inc, United States |
|---|---|
| FDA product code | HQD |
| Device type | Lens, Contact (Other Material) – Daily |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5916 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K213880 |
| Record published | 2024-04-08 |
| Record revised | 2026-03-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Optimum Exra (roflufocon D) Clear | In distribution | |
| Optimum Extreme (roflufocon E) Light Blue | In distribution | |
| Optimum Extreme (roflufocon E) Clear | In distribution | |
| Optimum Exra (roflufocon D) Light Blue | 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 |
| 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 |
| Boston XO2 | Bausch & Lomb Incorporated | 1 |
Showing 12 of 54. All products under Lens, Contact (Other Material) – Daily
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213880 | 2022-01-07 |
| K202860 | 2021-05-11 |
| K170335 | 2017-03-24 |
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.