Product code HQD
- Device name
- Lens, Contact (Other Material) - Daily
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.5916
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P880098S012 | MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | 2002-12-10 |
| P880098S011 | MENICON SF-P (TM) | Menicon Co, Ltd. | 2000-09-06 |
| P860022S052 | BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A) | Bausch & Lomb | 2000-02-04 |
| P860022S051 | ITAFLUOROFOCON A AND B | Bausch & Lomb | 1998-03-31 |
| P860022S050 | IPAFLUOROFOCON A AND B | Bausch & Lomb | 1998-03-31 |
| P860022S049 | IPAFLUOROFOCON A AND B | Bausch & Lomb | 1998-02-06 |
| P860022S048 | IPAFLUOROFOCON A AND B | Bausch & Lomb | 1997-10-15 |
| P870024S041 | FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES | CooperVision, Inc. | 1997-08-25 |
| P860022S047 | BOSTON EQUALENS(R) AND BOSTON RXD(R) | Bausch & Lomb | 1995-06-05 |
| P860022S046 | BOSTON EQUALENS(R) AND BOSTON RXD(R) | Bausch & Lomb | 1995-06-05 |
| P880024S003 | N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL | The Lagado Corp. | 1994-03-04 |
| P890046S027 | O-PERM F60 RGP CONTACT LENS | Optical Polymer Research, Inc. | 1994-03-01 |
| P890046S026 | O-PERM F60 RGP CONTACT LENS | Optical Polymer Research, Inc. | 1994-03-01 |
| P860022S040 | BOSTON(R) EQUALENS (R) SCLERAL CONTACT LENS DESIGN | Bausch & Lomb | 1994-03-01 |
| P920045S001 | OP-3 (TM) RGP CONTACT LENS | Stellar Contact Lens, Inc. | 1994-02-24 |
| P880024S002 | N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL | The Lagado Corp. | 1994-02-24 |
| P860022S045 | BOSTON EQUALENS(R) AND BOSTON RXD(R) | Bausch & Lomb | 1994-02-16 |
| P840055S032 | GAS PERMEABLE CONTACT LENSES | The Lifestyle Co., Inc. | 1994-02-04 |
| P840055S028 | RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B) | The Lifestyle Co., Inc. | 1994-01-31 |
| P890044S027 | TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES | Rand Scientific Corp. | 1994-01-26 |
| P890046S025 | O-PERM F60 RGP CONTACT LENS | Optical Polymer Research, Inc. | 1994-01-13 |
| P890072S010 | ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS | Progressive Chemical Research , Ltd. | 1994-01-07 |
| P890058S012 | NOVALENS (ROSILFOCON A) | Ocutec Corporation, Inc. | 1994-01-04 |
| P870024S040 | FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES | CooperVision, Inc. | 1994-01-04 |
| P870024S039 | FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES | CooperVision, Inc. | 1994-01-04 |
| P850038S023 | PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS | Paragon Optical Co. | 1994-01-04 |
| P850038S022 | PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS | Paragon Optical Co. | 1994-01-04 |
| P820056S056 | OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS | Paragon Vision Sciences | 1994-01-04 |
| P820056S055 | OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS | Paragon Vision Sciences | 1994-01-04 |
| P880001S040 | FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS | G.T. Laboratories, Inc. | 1993-11-23 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. | 2026-03-27 |
| K242393 | Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses | Acuity Polymers, Inc. | 2024-11-01 |
| K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | Tianjin Mastervision Technology Co., Ltd. | 2024-10-22 |
| K241571 | BostonSight® Specialty Lenses | Boston Foundation For Sight, Inc. D/B/A Bostonsight | 2024-08-14 |
| K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangib... | Acuity Polymers, Inc. | 2024-04-03 |
| K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) | Visionary Optics, LLC | 2024-02-21 |
| K230965 | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2023-06-16 |
| K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens | Acculens, Inc. | 2023-06-16 |
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | Paragon Vision Sciences, Inc. | 2023-05-05 |
| K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) | Visionary Optics, LLC | 2022-12-07 |
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Contamac, Ltd. | 2022-03-17 |
| K213880 | Custom Stable Rigid Gas Permeable Scleral Contact Lens | Valley Contax, Inc. | 2022-01-07 |
| K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2021-12-30 |
| K202860 | Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufoc... | Valley Contax, Inc. | 2021-05-11 |
| K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2021-04-09 |
| K201194 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2020-09-08 |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Incorporated | 2019-02-12 |
| K183175 | BostonSight Scleral | Bostonsight | 2019-01-04 |
| K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens | Contamac, Ltd. | 2018-11-23 |
| K181579 | eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K | E&E Optics, Inc. | 2018-07-26 |
| K180988 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2018-06-08 |
| K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens | Contamac, Ltd. | 2018-04-25 |
| K180172 | 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 ... | Paragon Vision Sciences | 2018-03-16 |
| K171575 | ENFLU 18 (enflufocon A) Daily Wear Contact Lens | Contamac, Ltd. | 2017-10-24 |
| K172314 | Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) | Art Optical Contact Lens, Inc. | 2017-09-20 |
| K171950 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) | Visionary Optics, LLC | 2017-08-16 |
| K171077 | HEXA100 (hexafocon A) Daily Wear Contact Lenses | Contamac, Ltd. | 2017-08-01 |
| K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017-07-17 |
| K170001 | Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2017-06-02 |
| K170007 | Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2017-05-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07899031699962 | Hidrocor Verde | SOLOTICA INDUSTRIA E COMERCIO LTDA | 2026-05-11 |
| 00850203008040 | Acuity | ACUITY POLYMERS, INC. | 2025-06-09 |
| 00850203008330 | Acuity | ACUITY POLYMERS, INC. | 2025-06-09 |
| 00860011844136 | Custom Stable | Valley Contax, Inc. | 2025-03-14 |
| 00860011844129 | Custom Stable | Valley Contax, Inc. | 2025-03-14 |
| 06974939049017 | EyeSpace Bespoke | Tianjin Mastervision Technology Co., Ltd. | 2025-01-21 |
| 06974939049048 | EyeSpace Scleral | Tianjin Mastervision Technology Co., Ltd. | 2025-01-21 |
| 06974939049031 | EyeSpace Scleral | Tianjin Mastervision Technology Co., Ltd. | 2025-01-21 |
| 06974939049024 | EyeSpace Bespoke | Tianjin Mastervision Technology Co., Ltd. | 2025-01-21 |
| 06974939049000 | SDJMASTERVISION | Tianjin Mastervision Technology Co., Ltd. | 2025-01-21 |
| 00860011844105 | Custom Stable | Valley Contax, Inc. | 2024-04-08 |
| 00860011844112 | Custom Stable | Valley Contax, Inc. | 2024-04-08 |
| B22225 | Oxfore100 | Paragon Vision Sciences, Inc. | 2023-09-18 |
| 00865576000249 | Optimum HR 1.51 | CONTAMAC HOLDINGS LIMITED | 2020-07-28 |
| 00865576000256 | Optimum HR 1.53 | CONTAMAC HOLDINGS LIMITED | 2020-07-28 |
| 00865576000270 | Hybird FS | CONTAMAC HOLDINGS LIMITED | 2020-07-28 |
| 00865576000294 | Optimum Infinite | CONTAMAC HOLDINGS LIMITED | 2020-07-28 |
| 00865576000225 | Optimum Comfort | CONTAMAC HOLDINGS LIMITED | 2020-07-22 |
| 00865576000232 | Optimum Classic | CONTAMAC HOLDINGS LIMITED | 2020-07-22 |
| 00865576000287 | HEXA100 | CONTAMAC HOLDINGS LIMITED | 2020-07-22 |
| 00865576000201 | Optimum Extra | CONTAMAC HOLDINGS LIMITED | 2020-07-22 |
| 00865576000218 | Optimum Extreme | CONTAMAC HOLDINGS LIMITED | 2020-07-22 |
| B22204 | Fluoroperm 92 | Paragon Vision Sciences, Inc. | 2018-03-23 |
| B22203 | Paraperm EW | Paragon Vision Sciences, Inc. | 2018-02-23 |
| B22201 | Optacryl 60 | Paragon Vision Sciences, Inc. | 2017-10-24 |
| 00785811435639 | Boston Equalens II | Bausch & Lomb Incorporated | 2017-10-18 |
| 00830002001015 | SGP | LIFESTYLE CO INC, THE | 2017-09-24 |
| 00830002002012 | SGP II | LIFESTYLE CO INC, THE | 2017-09-24 |
| 00884465092011 | MeniconZ (tisilfocon A) Clear | MENICON CO.,LTD. | 2016-06-20 |
| 00884465091014 | MeniconZ (tisilfocon A) Blue | MENICON CO.,LTD. | 2016-06-20 |