FDA 510(k)
FDA unclassified
Substantially Equivalent
🇬🇧 United Kingdom
LENSINE EXTRA STRENGTH CLEANER
K Number: K812433
·
Decision Sep 21, 1981
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
73
Applicant Total
97
Review Days
27
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Basic Information
- Device Name
- LENSINE EXTRA STRENGTH CLEANER
- K Number
- K812433
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- CooperVision, Inc.
- Date Received
- August 25, 1981
- Decision Date
- September 21, 1981
- Product Code
- HPX
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HPX | Lens, Contact (Polymethylmethacrylate) | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPX), ordered by most recent decision date.
PMMA CLASIC
FDA 510(k)
FDA Unclassified
·Unknown
KERATOPLASTY SUTURING LENS
FDA 510(k)
FDA Unclassified
·Unknown
MULTI-VIEW BIFOCALS
FDA 510(k)
FDA Unclassified
·Unknown
MARTIN-HENSLEY SEGMENT LENS
FDA 510(k)
FDA Unclassified
·Unknown
OPTIKEM PMMA CONTACT LENS
FDA 510(k)
FDA Unclassified
·Unknown
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by CooperVision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | Jan 25, 2024 | Substantially Equivalent |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | Feb 4, 2022 | Substantially Equivalent |
| K213164 | Avaira Vitality | Oct 26, 2021 | Substantially Equivalent |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | Oct 20, 2020 | Substantially Equivalent |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | Mar 23, 2020 | Substantially Equivalent |
| K190965 | MyDay | Apr 29, 2019 | Substantially Equivalent |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | Dec 11, 2018 | Substantially Equivalent |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | Jul 13, 2016 | Substantially Equivalent |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | Dec 23, 2013 | Substantially Equivalent |
| K131378 | SUS (STENFILCON A) CONTACT LENS | Aug 30, 2013 | Substantially Equivalent |