FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
K Number: K870265
·
Decision Feb 20, 1987
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
38
Applicant Total
97
Review Days
28
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Basic Information
- Device Name
- KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
- K Number
- K870265
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- CooperVision, Inc.
- Date Received
- January 23, 1987
- Decision Date
- February 20, 1987
- Product Code
- KYB
- 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 |
|---|---|---|---|
| KYB | Lens, Guide, Intraocular | FDA class 1 | Ophthalmic |
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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 |