VISALENS ALL PURPOSE SOLUTION FOR LENS
FDA 510(k) clearance K791523 · decided 1980-02-19
Clearance details
- K-number
- K791523
- Device name
- VISALENS ALL PURPOSE SOLUTION FOR LENS
- Applicant
- Pfizer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-08-10
- Decision date
- 1980-02-19
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- HPX
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PMMA CLASIC (K955777) | Rand Scientific Corp. | 1996-05-16 |
| KERATOPLASTY SUTURING LENS (K940106) | Visionary Technologies of Miami, Inc. | 1994-05-25 |
| MULTI-VIEW BIFOCALS (K913081) | Camp Contact Lenses | 1991-10-23 |
| MARTIN-HENSLEY SEGMENT LENS (K897021) | Bruce W. Martin O.D. and Edward Hensley | 1990-06-22 |
| OPTIKEM PMMA CONTACT LENS (K895411) | Optikem Polymers, Inc. | 1990-02-27 |
| ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY (K874591) | Vitreo Dynamics, Co. | 1988-05-03 |
| CHARTER HARD CONTACT LENS CLEANING SOLUTION (K865111) | Paco Pharmaceutical Services, Inc. | 1987-01-20 |
| BL1 (HARD CONTACT LENS) (K864343) | Beta Labs, Inc. | 1986-11-28 |
| CHARTER LABORATORIES INC. LENS LUBRICANT (K863974) | Paco Pharmaceutical Services, Inc. | 1986-11-10 |
| CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES (K862952) | Paco Pharmaceutical Services, Inc. | 1986-09-25 |
| AQUALUX LENS CASE (K862811) | Safeway Products, Inc. | 1986-09-03 |
| STYLEKEEPER CONTACT LENS CARRYING CASE (K861643) | Allergan, Inc. | 1986-06-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), (N18286/S041) | Pfizer, Inc. | 2023-05-16 |
| (Gelfoam (absorbable gelatin) Sterile Sponge) (N18286/S040) | Pfizer, Inc. | 2022-06-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S039) | Pfizer, Inc. | 2021-07-08 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S038) | Pfizer, Inc. | 2021-05-07 |
| Gelfoam Sterile Sponge (N18286/S037) | Pfizer, Inc. | 2021-02-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S036) | Pfizer, Inc. | 2020-12-10 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S035) | Pfizer, Inc. | 2020-03-19 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S034) | Pfizer, Inc. | 2020-02-27 |