IN A WINK LUBRICATING & REWETTING DROPS
FDA 510(k) clearance K853445 · decided 1985-11-29
Clearance details
- K-number
- K853445
- Device name
- IN A WINK LUBRICATING & REWETTING DROPS
- Applicant
- Ciba Vision Care
- Decision
- Substantially Equivalent
- Date received
- 1985-08-16
- Decision date
- 1985-11-29
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- HPX
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Atlanta, GA, 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 |
|---|---|---|
| AOSEPT DISINFECTANT (P820040/S033) | Ciba Vision Care | 1995-12-13 |
| AOSEPT (R) LENS CUP & AODISC NEUTRALIZER (P820040/S032) | Ciba Vision Care | 1995-10-23 |
| OSEPT(R) & LENSEPT(R) SOLUTIONS (P820040/S030) | Ciba Vision Care | 1994-09-30 |
| CIBATINT(TM) TINTING PROCESS (P820086/S011) | Ciba Vision Care | 1993-11-23 |
| CIBA OPAQUE(TEFILICON)(HYDROPHILIC) CONTACT LENS (P810005/S027) | Ciba Vision Care | 1991-12-10 |
| LENSEPT(R) DISINFECTION SYSTEM (P820040/S031) | Ciba Vision Care | 1991-12-10 |
| SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S026) | Ciba Vision Care | 1991-08-08 |
| WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS (P810005/S026) | Ciba Vision Care | 1991-08-06 |