FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
VFS 1000/SCREENING FUNCTION ANALYZER
K Number: K830011
·
Decision Jan 17, 1983
Classifications
1
FEI Numbers
106
Registration Numbers
107
Same Product Code
31
Applicant Total
97
Review Days
14
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Basic Information
- Device Name
- VFS 1000/SCREENING FUNCTION ANALYZER
- K Number
- K830011
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- CooperVision, Inc.
- Date Received
- January 3, 1983
- Decision Date
- January 17, 1983
- Product Code
- HOX
- Advisory Committee
- Ophthalmic
- 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 |
|---|---|---|---|
| HOX | Chart, Visual Acuity | FDA class 1 | Ophthalmic |
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| 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 |