Product code MWL
- Device name
- Lens, Contact (Rigid Gas Permeable), Extended Wear
- Medical specialty
- Ophthalmic
- Device class
- 3
- Regulation number
- 886.5916
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P860022S061 | Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A) | Bausch & Lomb | 2025-12-16 |
| P860022S060 | Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl | Bausch & Lomb | 2024-07-18 |
| P990018S010 | ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti | Menicon Co, Ltd. | 2023-06-16 |
| P990018S007 | Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight | Menicon Co, Ltd. | 2022-11-16 |
| P870024S060 | FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid | CooperVision, Inc. | 2022-06-16 |
| P870024S059 | Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4™ Rigid Gas Permeable Contact Lenses in Clear and Tin | CooperVision, Inc. | 2022-06-08 |
| P870024S062 | Paragon CRT Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Rigid Gas Permeable Contact Lenses in Clear an | CooperVision, Inc. | 2022-05-10 |
| P870024S058 | Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints | CooperVision, Inc. | 2021-04-23 |
| P870024S057 | Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin | CooperVision, Inc. | 2020-08-31 |
| P870024S056 | Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti | CooperVision, Inc. | 2020-08-31 |
| P870024S055 | Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac | CooperVision, Inc. | 2020-08-18 |
| P870024S054 | Paragon HDS 100 and Fluoroperm 151 (paflufocon D) Rigid Gas Permeable Contact Lens in Clear and Tints | CooperVision, Inc. | 2020-08-13 |
| P870024S051 | Paragon CRT (paflufocon B), Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) and Paragon RG-4 (paflu | CooperVision, Inc. | 2019-07-11 |
| P870024S052 | FluoroPerm 92, FluoroPerm 60, FluoroPerm 30, FluoroPerm 151, HDS and HDS 100 | CooperVision, Inc. | 2019-07-03 |
| P860022S059 | BOSTON EQUALENS, EQUALENS II (ITAFLUROFOCON A)& (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Bausch & Lomb | 2016-07-25 |
| P870024S049 | PARAGON CRT, PARAGON CRT 100, PARAGON RG-4 RIGID GAS PERMABLE CONTACT LENS | CooperVision, Inc. | 2014-07-28 |
| P050031S001 | PARAGON CRT LENS | CooperVision, Inc. | 2014-07-28 |
| P860022S058 | BOSTON EQUALENS/EQUALENS II | Bausch & Lomb | 2011-06-22 |
| P010062S009 | BOSTON ORTHOKERATOLOGY SHAPING LENS FOR OVERNIGHT WEAR | Bausch & Lomb | 2011-06-22 |
| P990018S004 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | 2010-02-25 |
| P870024S047 | RIGID GAS PERMEABLE CONTACT LENS | CooperVision, Inc. | 2009-12-11 |
| P870024S046 | PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON C) AND PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON B) | CooperVision, Inc. | 2009-04-29 |
| P860022S057 | BOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE LENS | Bausch & Lomb | 2008-02-21 |
| P860022S056 | BOSTON EQUALENS (ITAFLUOROFOCON A AND OPRIFOCON A) | Bausch & Lomb | 2006-05-30 |
| P860022S055 | BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR EXTENDED WEAR | Bausch & Lomb | 2003-11-25 |
| P990018S003 | MENICON Z | Menicon Co, Ltd. | 2002-11-06 |
| P990018S002 | MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR | Menicon Co, Ltd. | 2002-07-12 |
| P860022S054 | BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS | Bausch & Lomb | 2002-05-06 |
| P860022S053 | BOSTON EQUALENS/BOSTON EQUALENS II | Bausch & Lomb | 2001-11-21 |
| P990018S001 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | 2000-09-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00192538901086 | MeniconZ (tisilfocon A) Red | MENICON CO.,LTD. | 2023-06-09 |
| B22205 | Fluoroperm 60 | Paragon Vision Sciences, Inc. | 2018-03-23 |
| B22207 | Fluoroperm 151 | Paragon Vision Sciences, Inc. | 2018-03-23 |
| B22208 | Paragon HDS | Paragon Vision Sciences, Inc. | 2018-03-23 |
| B22209 | Paragon HDS100 | Paragon Vision Sciences, Inc. | 2018-03-23 |
| B22204 | Fluoroperm 92 | Paragon Vision Sciences, Inc. | 2018-03-23 |
| B22203 | Paraperm EW | Paragon Vision Sciences, Inc. | 2018-02-23 |
| 00785811435622 | Boston Equalens | Bausch & Lomb Incorporated | 2017-10-18 |
| 00785811435639 | Boston Equalens II | Bausch & Lomb Incorporated | 2017-10-18 |
| 00884465091014 | MeniconZ (tisilfocon A) Blue | MENICON CO.,LTD. | 2016-06-20 |
| 00884465092011 | MeniconZ (tisilfocon A) Clear | MENICON CO.,LTD. | 2016-06-20 |