Product code HPX
- Device name
- Lens, Contact (Polymethylmethacrylate)
- Medical specialty
- Unknown
- Device class
- U
- 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 |
|---|---|---|---|
| P820065S082 | BOSTON LENS II & IV | Polymer Technology Corp. | 1994-02-16 |
| P820063S055 | PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS | CooperVision, Inc. | 1994-01-04 |
| P820063S054 | PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS | CooperVision, Inc. | 1994-01-04 |
| P840004S007 | SATURN II(TM) (SYNERGICON A) CONTACT LENS | Wesley Jessen Corp. | 1993-10-14 |
| P820065S081 | BOSTON LENS II & IV | Polymer Technology Corp. | 1993-09-07 |
| P820065S080 | BOSTON LENS II & IV | Polymer Technology Corp. | 1993-09-07 |
| P840004S006 | SATURN II(TM) (SYNERGICON A) CONTACT LENS | Wesley Jessen Corp. | 1993-05-13 |
| P820063S053 | PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS | CooperVision, Inc. | 1993-04-14 |
| P820065S079 | BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION | Polymer Technology Corp. | 1992-08-06 |
| P820063S051 | PARAPERM O2 (PASIFOCON A) BROWN ,GRAY TINT | CooperVision, Inc. | 1992-06-11 |
| P820065S078 | BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION | Polymer Technology Corp. | 1992-04-06 |
| P820063S052 | PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS | CooperVision, Inc. | 1992-03-30 |
| P820065S077 | BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS | Polymer Technology Corp. | 1992-02-20 |
| P820063S050 | PARAPERM O2 (PASIFOCON A) CONTACT LENS | CooperVision, Inc. | 1992-02-20 |
| P820065S076 | BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS | Polymer Technology Corp. | 1992-01-14 |
| P850068S006 | SILSOFT (ELASTOFILCON A) CONTACT LENSES | Bausch & Lomb, Inc. | 1991-11-15 |
| P850068S005 | SILSOFT (ELASTOFILCON A) CONTACT LENSES | Bausch & Lomb, Inc. | 1991-11-15 |
| P850068S007 | SILSOFT (ELASTOFILCON A) CONTACT LENSES | Bausch & Lomb, Inc. | 1991-10-30 |
| N18120S024 | POLYCON CONTACT LENS | Wesley Jessen Corp. | 1991-09-06 |
| P820063S049 | PARAPERM O2 (PASIFOCON A) CONTACT LENS | CooperVision, Inc. | 1991-08-15 |
| N18120S027 | POLYCON (SILAFOCON A) CONTACT LENSES | Wesley Jessen Corp. | 1991-06-24 |
| P820065S075 | BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS | Polymer Technology Corp. | 1991-04-05 |
| P820065S074 | BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS | Polymer Technology Corp. | 1991-03-21 |
| P820063S048 | PARAPERM O2 (PASIFOCON A) CONTACT LENS | CooperVision, Inc. | 1991-02-05 |
| P820065S073 | BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS | Polymer Technology Corp. | 1991-02-04 |
| P890020S001 | FLUOROCON TM-60 | Ciba Vision Corporation | 1990-12-28 |
| P820065S072 | BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS | Polymer Technology Corp. | 1990-12-12 |
| P820063S047 | PARAPERM O2 (PASIFOCON A) CONTACT LENS | CooperVision, Inc. | 1990-10-31 |
| P820065S071 | BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS | Polymer Technology Corp. | 1990-10-24 |
| P850068S002 | SILSOFT (ELASTOFILCON A) CONTACT LENSES | Bausch & Lomb, Inc. | 1990-09-11 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955777 | PMMA CLASIC | Rand Scientific Corp. | 1996-05-16 |
| K940106 | KERATOPLASTY SUTURING LENS | Visionary Technologies of Miami, Inc. | 1994-05-25 |
| K913081 | MULTI-VIEW BIFOCALS | Camp Contact Lenses | 1991-10-23 |
| K897021 | MARTIN-HENSLEY SEGMENT LENS | Bruce W. Martin O.D. and Edward Hensley | 1990-06-22 |
| K895411 | OPTIKEM PMMA CONTACT LENS | Optikem Polymers, Inc. | 1990-02-27 |
| K874591 | ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY | Vitreo Dynamics, Co. | 1988-05-03 |
| K865111 | CHARTER HARD CONTACT LENS CLEANING SOLUTION | Paco Pharmaceutical Services, Inc. | 1987-01-20 |
| K864343 | BL1 (HARD CONTACT LENS) | Beta Labs, Inc. | 1986-11-28 |
| K863974 | CHARTER LABORATORIES INC. LENS LUBRICANT | Paco Pharmaceutical Services, Inc. | 1986-11-10 |
| K862952 | CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES | Paco Pharmaceutical Services, Inc. | 1986-09-25 |
| K862811 | AQUALUX LENS CASE | Safeway Products, Inc. | 1986-09-03 |
| K861643 | STYLEKEEPER CONTACT LENS CARRYING CASE | Allergan, Inc. | 1986-06-02 |
| K860677 | EASY EYES TM LENS CARRYING CASE | Applied Laboratories, Inc. | 1986-05-29 |
| K861642 | LENSKEEPER CONTACT LENS CARRYING CASE | Allergan, Inc. | 1986-05-29 |
| K861712 | WETTING & SOAKING HARD CONTACT LENS SOLUTION | Maurry Biological Co. | 1986-05-29 |
| K854968 | BAUSCH & LOMB LENS CARRYING CASE | Bausch & Lomb, Inc. | 1986-04-04 |
| K853808 | HARD CONTACT LENS CLEANING & SOAKING SOLUTION | Maurry Biological Co. | 1986-03-11 |
| K853809 | DAILY HARD CONTACT LENS CLEANER | Maurry Biological Co. | 1986-03-11 |
| K854442 | UVASORB-400 | Optatint, Inc. | 1986-02-19 |
| K853810 | WETTING SOLUTION FOR HARD CONTACT LENSES | Maurry Biological Co. | 1985-12-16 |
| K853807 | ALL-IN-ONE HARD CONTACT LENS SOLUTION | Maurry Biological Co. | 1985-12-16 |
| K853811 | HARD CONTACT LENS SOAKING SOLUTION | Maurry Biological Co. | 1985-12-16 |
| K853729 | KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) | Ryder Intl. Corp. | 1985-12-13 |
| K853728 | KESTREL CONTACT LENS STORAGE CASE(NORYL) | Ryder Intl. Corp. | 1985-12-13 |
| K853870 | EASY EYES TM LENS CARRYING CASE | Applied Laboratories, Inc. | 1985-12-10 |
| K853445 | IN A WINK LUBRICATING & REWETTING DROPS | Ciba Vision Care | 1985-11-29 |
| K850909 | RHODA-LUX LENS BLANKS | Optatint, Inc. | 1985-10-04 |
| K852384 | SIGHT SAVER ALL PURPOSE LENS CARRYING CASE | Bausch & Lomb, Inc. | 1985-07-31 |
| K851887 | ON TARGET | Newman Assoc. | 1985-05-30 |
| K851497 | MARLIN CONTACT LENS CASE | Marlin Industries | 1985-05-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B22202 | Paraperm O2 | Paragon Vision Sciences, Inc. | 2018-02-23 |
| 00858174006003 | PMMA | LAGADO CORPORATION, THE | 2016-07-29 |